CPHI Online is the largest global marketplace in the pharma ingredients industry

  • Products
    0
  • Companies
    0
  • Articles
    0
  • Events
    0
  • Webinars
    0

Pharmaceutical toxicology consulting

Pharmaceutical toxicology consulting
Product Description

Intertek offers wide range of pharmaceutical services which includes pharmaceutical toxicology consulting. It belongs to pharmaceutical and healthcare consulting services category. It includes design, implementation, and management of nonclinical testing programs with a focus on company goals (e.g. First-in-human trials and achieving proof of concept, phase ii to full market registration support), review, interpretation, and positioning of data (toxicology study reports, literature, safety data), toxicology issues resolution, including interactions with regulatory authorities and the preparation of white papers, gap analysis and independent data reviews, etc.

Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain

Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain

More Products from Intertek Pharmaceutical Services (99)

  • Physical characterization techniques for pharmaceuticals

    Product Physical characterization techniques for pharmaceuticals

    Intertek offers wide range of pharmaceutical services which includes physical characterization techniques for pharmaceuticals. Our experts can assist with formulation or process development, quality control, gmp lot release testing, and investigational manufacturing troubleshooting. It includes microscopy,...
  • Post-translational modifications

    Product Post-translational modifications

    Intertek offers wide range of pharmaceutical services which includes post-translational modifications. It belongs to biopharmaceutical protein analysis services category. It includes deamidation, glycosylation, glycylation, phosphorylation, acetylation , alkylation, sulfation, etc.
  • Glass delamination and Interaction studies

    Product Glass delamination and Interaction studies

    The phenomenon of glass delamination is a serious quality issue. Delamination is characterised by the formation of small glass flakes, also known as lamellae, which are shed from the internal surface of the glass container, pH changes and extraction of ions from the glass material leaching into the product...
  • Pharmacokinetic (pk) analysis

    Product Pharmacokinetic (pk) analysis

    Intertek offers wide range of pharmaceutical services which includes pharmacokinetic (pk) analysis. It belongs to bioanalytical services for preclinical and clinical studies category. Contact us for more information.
  • Process residuals analysis

    Product Process residuals analysis

    Intertek offers wide range of pharmaceutical services which includes process residuals analysis. It belongs to biopharmaceutical protein analysis services category. It includes antibiotics – kanamycin, tobramycin, gentamycin, amoxicillin, chloramphenicol, methotrexate, glutathione, dithiothreitol (dtt...
  • Pharmaceutical powder and particle morphology

    Product Pharmaceutical powder and particle morphology

    Intertek offers wide range of pharmaceutical services which includes pharmaceutical powder and particle morphology. It belongs to pharmaceutical analysis services category. It includes dry powder analysis: physical characterisation, particle morphology using malvern morphologi g3, particle size analysis – ...
  • Reference standard materials program

    Product Reference standard materials program

    Intertek offers wide range of pharmaceutical services which includes reference standard materials program. It belongs to pharmaceutical analysis services category. It includes initial characterization, generation of a certificate of analysis, expiry dating through stability testing with ich stability stora...
  • Regenerative medicine analysis & certification

    Product Regenerative medicine analysis & certification

    Intertek offers wide range of pharmaceutical services which includes regenerative medicine analysis & certification. It belongs to medical devices services category. It includes qc testing services, stability studies, extractables and leachables, biomechanical testing of scaffolds, physical characterizatio...
  • Medical Device Testing

    Product Medical Device Testing

    R&D Analytical SupportIntertek’s significant expertise in bioanalysis and clinical pharmacokinetic studies allows us to support medical device companies working in the areas of preclinical and clinical drug development. Our support services include assay development for API’s, impurities, trace metals ...
  • Total protein quantification

    Product Total protein quantification

    Intertek offers wide range of pharmaceutical services which includes total protein quantification. It belongs to biopharmaceutical protein analysis services category. It includes amino acid analysis, absorbance at 280nm. Lowry assay, bradford assay, bca assay, etc.
  • Large molecule bioanalytical services

    Product Large molecule bioanalytical services

    Intertek offers wide range of pharmaceutical services which includes large molecule bioanalytical services. It includes immunochemistry services, quantitative immunoassays, immunogenicity assays, biomarkers assays and validation, cell-based neutralization assays, ligand-binding assays, etc.
  • Wound care analysis

    Product Wound care analysis

    Intertek offers wide range of pharmaceutical services which includes wound care analysis. It belongs to medical devices services category. It includes quantification of level of components (inorganic or organic), loading / dosing studies, in vitro simulated antimicrobial active release studies, competitor ...

Intertek Pharmaceutical Services resources (84)

  • News Boosting in Vitro Testing for Nasal Drug Products

    In Vitro Test Methods for Nasal Drug Products VIDEO: Learn how our Alberta Idealised Nasal Inlet (AINI) capability can deliver enhanced IVBE studies for generics and support the development of novel intranasal products targeting specific nasal regions 
  • Brochure Brochure - Pharmaceutical Services

    Covering our full breadth of contract laboratory services, auditing and regulatory consultancy expertise, this brochures provides a summary of our global capabilities.
    Visit www.intertek.com/pharmaceutical for more information.
  • Sponsored Content Intertek’s Pharmaceutical Audit Services Team celebrates 15 years of excellence

    Celebrating 15 years of delivering flexible auditing solutions for the global healthcare, pharmaceutical, and cosmetics sectors, our Pharmaceutical Audit Services Team have continually innovated to build a set of relevant auditing services to help clients meet the evolving challenges of driving quality and visibility across complex global supply chains.

  • Brochure Brochure - Inhalation Drug Product Development Expertise

    Our inhalation product experts have been working in the inhaled and nasal fields for nearly 30 years and possess the necessary experience to help design, implement and support full development, stability and testing services which are designed to provide the right information at the right time. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
  • News The Vaccine and Therapeutics Development Digital Resources Have Been Released

    Our library of digital resources is available to enhance your knowledge-base and educate you along every step of the drug development process. Keep up-to-date with industry hot topics and the latest research developed by our thought-leaders. 
  • Brochure Poster - Top 5 Considerations for Outsourcing Stability Storage

    WHAT SHOULD YOU EXPECT FROM YOUR OUTSOURCING PARTNER? WHAT DOES YOUR OUTSOURCING PARTNER NEED FROM YOU? 
    Intertek Melbourn have provided GMP stability storage services since 2004. Our Stability team are currently coordinating over 200 stability studies for more than different 30 clients from across all global territories. We offer over 375,000L of capacity over various conditions, including ICH and bespoke conditions.
  • News Expansion in characterisation and development support for mRNA vaccines and therapeutics.

    Intertek Pharmaceutical Services has expanded laboratories services supporting mRNA vaccine and therapeutic products. At our GLP / GCP / GMP laboratories, scientists can test mRNA drug substance or drug products to help you confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA. Additionally, our experts provide mRNA specific methods including integrity, potency, capping efficiency, residual DNA template, residual dsRNA and delivery system testing. 
  • Brochure Poster - Flexible Outsourcing Solutions, Laboratory Services

    Our team support you across your development and production lifecycle including cGMP and GLP/GCP compliant characterization, stability, release testing and bioanalysis. You will need a strategic partner who invests in scientific and technical excellence to help you to develop and launch a pipeline of new products that meet the needs of patients, buyers and consumers.
  • Brochure Brochure - Oligonucleotide Analytical Development Services

    Our scientists have supported oligo medicine drug development since the inception of this class of therapeutics. Through our dedicated suite of characterisation techniques we are focused on helping you to meet industry requirements for regulatory compliant (GMP or GLP) characterisation and quality control for oligonucleotide based drugs. Bringing quality and safety to life, our Total Quality Assurance expertise is delivered consistently to help you ensure you meet and exceed your quality, safety and efficacy requirements. 
  • Brochure Brochure - Biopharmaceutical Analytical Development Support

    We have nearly 30 years of experience in biopharmaceutical development support across a wide range of product types, including proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, peptides, cytokines (e.g., interferons), oligonucleotides, glycoproteins, and biosimilars. With broad capabilities in Europe and North America, our Total Quality Assurance expertise is delivered consistently to help you meet and exceed your quality, safety, and efficacy requirements. Intertek's experts provide strong scientific and technical leadership, coupled with project management and regulatory support, to drive your development and manufacturing programs forward.
  • Brochure Brochure - Bioanalysis Services

    Bioanalysis plays a critical role in the assessment of drug safety and efficacy. We understand that each project presents its unique challenges, and by applying our nearly 30 years of experience in conducting regulatory bioanalytical studies, our teams work closely with you to ensure that the best possible solutions are delivered, optimizing value for your programs. With Intertek as your partner, you have access to the scientific and regulatory knowledge of our bioanalytical experts, so that you can leverage the insight we bring to accelerate your drug development.
  • Brochure Brochure - mRNA Vaccine & Therapeutic Products Analytical Development Services

    By integrating advanced analytical technology with a heritage supporting pharmaceutical product development, our experts offer Total Quality Assurance to help you ensure the safety, efficacy, and quality of your mRNA therapy.
  • Technical Data Factsheet - ATMP Analytical Development Services

    The complexity of Advanced Therapy Medicinal Products (ATMPs)  and their mode of action, present many challenges to development. Our experts provide analytical development and routine testing to help you meet regulatory expectations for safety and efficacy. 
  • Technical Data Factsheet - Biomarker Services

    Fit-for-purpose solutions for exploratory and confirmatory biomarkers.
  • Whitepaper Whitepaper - Stability Studies Across the Drug Product Lifecycle

    Stability studies play a fundamental role across the lifecycle of pharmaceutical products to demonstrate that a new drug substance or drug product is within acceptable chemical and physical limits.

    A host of considerations must be incorporated into the study design at the outset, with many variables that depend on the product type, the development phase, and the region that the product will be marketed in. In this paper, Tasmina Bokhari, Stability Team Leader, provides a review of the role stability studies play across the product development process.

    Download whitepaper: www.intertek.com/pharmaceutical/stability-studies-drug-product-lifecycle

  • Whitepaper Whitepaper - Quality Control of Oligonucleotide Therapeutics

    In this whitepaper, our oligonucleotide services experts describe analytical approaches to achieve identification and and characterisation including melting temperature determination, structural characterisation using NMR and high resolution mass spectrometry and determination of product or process related impurities.

  • Whitepaper Whitepaper - Evaluating Properties of Liposomes

    In this whitepaper our expert, describes analytical approaches to evaluate the physicochemical properties of liposomes for drug delivery systems according to the FDA Guidance for Liposome Drug Products.
  • Whitepaper Whitepaper - Monitoring of Glycosylation Analytical Approaches for Antibody-Based Therapeutics

    An introduction to N-linked glycosylation and available approaches for characterization.

    N-linked glycosylation is a common post-translational modification on many antibody-based therapeutics, and has been linked to safety, stability and activity. Glycosylation should therefore be monitored and controlled.

    In this white paper, our expert Michael Walker discusses complementary N-linked glycosylation characterization techniques that give relative levels of different glycoforms at specific sites and compares them to more common methodologies of enzymatic stripping and fluorescent labelling.

    Download whitepaper: www.intertek.com/pharmaceutical/glycosylation-analytical-approaches-whitepaper-intertek
  • Whitepaper Article - Addressing Key Attributes of Viral Vectors

    In this article our expert describes key considerations for the characterization of viral vectors including a case study focusing on the determination of empty vs full capsids.

  • Whitepaper Whitepaper - GMP Flow Cytometry

    In this whitepaper our expert describes the applications, considerations and challenges of utilizing Flow Cytometry techniques in a regulatory environment.
  • Whitepaper Article - A Strategic Approach to Nitrosamine Screening in Drug Products

    In this article our expert describes a strategy for screening nitrosamines that delivers clear and accurate results and avoids false positives, by applying both LC-MS/MS and HRMS techniques.

  • Whitepaper EBook - Flexible Contingency Outsourcing Solutions

    In this e-book, our expert looks at how a partnership with an experienced CRO can enable your business continuity through flexible analytical laboratory solutions with a focus on efficient method transfer.

  • Whitepaper Article - CMC Considerations for mRNA Based Therapeutics

    This article discusses analytical approaches to characterise mRNA in early-stage development to support effective therapeutic programs.
  • Whitepaper Article - New Approaches to Bioassay Design

    In this article our expert describes new approaches to study design that lead to reliable, more robust cell potency assays.
  • Whitepaper Article - Challenges in mAb Characterisation

    In this article our experts describe the challenges which must be overcome when characterizing monoclonal antibodies in a GMP environment.
  • Whitepaper Article - Characterisation of Bispecifics

    In this article our experts describe key considerations for the characterisation of bispecific antibodies.
  • Whitepaper Whitepaper - Repurposing Vaccines for Intranasal Development

    Repurposing Vaccines for Intranasal Development
    Benefits, Challenges and Considerations For a Non-Invasive Yet Effective Delivery

    Intranasal vaccination offers significant benefits including ease of administration, and the potential induction of mucosal-specific as well as systemic immunity. Liquid and dry powder formulations can be delivered by intranasal routes. Challenges to development though, are posed by inefficient absorption, low permeability of the nasal tissues for high molecular weight therapeutics, and rapid mucociliary clearance, amongst others.In this article, Mark Parry, Technical Director, describes the challenges to intranasal delivery with a focus on how strategic formulation and device selection for mucosal vaccine delivery can help overcome development challenges.
    Download whitepaper: 
    www.intertek.com/pharmaceutical/repurposing-vaccines-vaccines-intranasal-development
  • Whitepaper WHITEPAPER - Download: Extractables and Leachables Strategies for Pharmaceutical Production Tubing

    In order to mitigate the risks of potentially harmful substances leaching from contact materials or process tubing into a medicinal/pharmaceutical product which may present a health risk to the patient, a robust approach to extractables and leachables (E&L) studies is required in order to gain a good understanding of the materials in the tubing products. In this short article, our expert, Dr Tino Otte, Senior Scientific Consultant, describes the steps of a rigorous E&L study that can be taken to ensure safe and high-quality materials and tubing products
  • Whitepaper Article - Overcoming Challenges to Inhaled Biologic Development

    The significance and challenges of delivering a biologic drug to the lungs and the nose.
    Inhaled biologics have been forecast to grow in importance due to the fact that inhalation presents a highly attractive route for the administration of various classes of large molecule, particularly for the treatment of respiratory diseases. Here, Chris Vernall, Business Development Director, Intertek Pharmaceutical Services, discusses the significance and difficulties of biologics in the inhalables sector, and how Intertek’s Centre of Excellence for Inhaled and Nasal Biologics provides valuable services for those developing products in this area.

  • Whitepaper Article - Nebulised Drug Development Considerations

    Nebuliser delivery of drugs offers a patient-friendly means of transforming a medicine into a breathable aerosol. They offer the advantage, over other types of inhaled device (such as pMDIs or DPIs), in that they do not require such strict patient coordination between inhalation and actuation, and so they are effective for the treatment of paediatric, elderly, ventilated and sedated patients.
    Intertek Melbourn have been supporting clients’ product development for nearly 30 years across all classes of inhaled and nasal delivery technologies including nebulised therapeutics. In this bite-sized article our Formulation and Manufacturing Lead, David Ward, shares some considerations for successful development of nebulised drugs.
  • Whitepaper Article - In Vitro Bioequivalence for Pulmonary and Nasal Delivery

    With a focus on bioequivalence testing in the development of generic inhalables, Mark Parry, Technical Director, Intertek Melbourn, highlights some of the shortcomings of aerodynamic particle size distribution and delivered dose testing, and introduces newer testing techniques that Intertek offers to allow its clients to de-risk clinical studies or even to support robustly in vitro data submissions as to avoid clinical work.
  • Whitepaper Whitepaper - Glass Delamination Studies for Pharmaceutical Vials

     The phenomenon of glass delamination is a serious quality issue. Delamination is characterised by the formation of small glass flakes, also known as lamellae, which are shed from the internal surface of the glass container, pH changes and extraction of ions from the glass material leaching into the product – all of which have significant potential to compromise product quality whilst also compromising the overall glass structure.

    This white paper summarises testing approaches (such as USP<1660>), predictive screening studies, interaction studies, leaching experiments and microscopy investigations which can help to mitigate the risks which glass delamination pose to product quality and patient safety.
  • Whitepaper Whitepaper - Extractables and Leachables Strategies for Transdermal Delivery Patch Products

    Transdermal delivery patches often contain multiple materials, adhesives and inks which increase the risk of unwanted leaching of potentially harmful substances from these materials. Such substances may penetrate the skin barrier and into the patient. For this reason, strategically designed extractables and leachables (E&L) studies are of critical importance to the development of transdermal delivery products.
    In this application note, Dr Tino Otte, Senior Scientific Consultant, Intertek Reinach, describes the steps required to implement and adapt an E&L study design for a transdermal delivery patch device.
  • Whitepaper Strategic Partnerships with Contract Lab Services Organizations

    We describe the critical attributes required for a successful strategic partnership between a Contract Laboratory Organisation and sponsor and the benefits that this approach can yield. Download now to learn from our experts.
  • Whitepaper Intranasal Delivery of Biologic Therapeutics

    We look at how the nasal route of drug administration offers the potential to improve delivery of biologics and why strategic formulation is required to make this a reality.
  • Video VIDEO - Cell and Gene Therapy Analytical Development Services

    Intertek's cell and gene therapy experts provide analytical development to help you meet regulatory expectations for safety and efficacy of your products. Cell and gene therapies are complex medicines for human use that are based on genes, tissues or cells. In addition, these may be incorporated into a delivery technology or a medical device. The wide variety of products within this category and their inherent complexity means that each will present different analytical development challenges and so specific characterisation, potency, purity and identity assays are required for each product. 
    Learn more: 
    www.intertek.com/pharmaceutical/biopharmaceuticals/gene-therapy-characterisation
  • Video WEBINAR - Translating Inhaled and Nasal Technologies for the Delivery of Biologics

    Inhaled and nasal delivery platforms have specific applications outside of their traditional uses for asthma/chronic obstructive pulmonary disease (COPD) and seasonal rhinitis/sinusitis: They can offer real advantages for the delivery of therapeutic biologics. During this short presentation, Intertek's Technical Director, Mark Parry, will provide an overview of currently available technologies and successfully marketed products, with a look at the development challenges that might be encountered — and the solutions that are available — when formulating these delivery routes. Mark will also describe key considerations when rapidly repurposing existing products for inhaled delivery.
  • Video WEBINAR - Design of Robust Extractables and Leachables Studies

    To ensure patient safety, precise knowledge about potential contamination associated with a drug product container closure systems (CCS) or single use process equipment is critical. As the complexity of materials and construction of CCS or process equipment increases, the risk of leachables being introduced as drug impurities increases significantly. Authorities are focused on accurate determination of leachables present in the real drug matrix and this demands the need for sensitive and robust analytical effort and interpretation of complicated complicates data.
    During this presentation, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, focuses on how to design a robust extractables and leachables study design which covers all necessary steps to meet regulatory expectations whilst highlighting potential challenges of such a study with strategies and examples of how to address these challenges.
  • Video VIDEO - GMP Cryo-TEM Services

    This video describes Intertek's GMP Cryo-TEM Services supporting the development of safe and effective advanced therapies.
  • Video WEBINAR - Extractables and Leachables Studies for Process Materials and Container Closure Systems

    In this webinar, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, discuss extractables and leachables studies which have been performed on multiple product types and contact materials. With increasing focus by the authorities on the accurate determination of leachables in real formulations, one of the biggest challenges is to differentiate between matrix related degradation products and real leachables from the packaging or contact materials. Typical examples and case studies will illustrate how, through a strategic approach, it is possible to differentiate between the two. Furthermore, these case studies will illustrate why it is important to analyse leachables in the actual formulation and not only in extraction solutions.
  • Video WEBINAR - Analytical Approaches for Identification and Quantification of Impurities In Pharmaceuticals

    The characterization and quantification of impurities in pharmaceutical products is a critical part of quality control. In many cases, routine analysis techniques are not sufficient to fully characterize the impurity profile due to overlapping of peaks, low peak intensity or inaccurate mass detection. Even if the correct molar mass of a compound is known, multiple structures are still possible and the real concentration often cannot be detected due to absence of chemically similar standards. In this webinar, our expert speaker Sandro Laiso we will highlight different approaches to characterize impurities in pharmaceutical products, step by step, making use of unique combinations of analytical techniques such as PRE-LC, HR-MS or qNMR. 
  • Video WEBINAR - Repurposing Products for Inhaled Delivery - Rapid Response Strategies

    Delivery to the lungs is important for COVID-19 and there is currently an unprecedented need to accelerate development of effective therapies and vaccines. There is a focus on repurposing existing candidates as a strategic route to get the products to patients faster, however, many candidates are not yet in a format suitable for delivery to the lungs. Redevelopment must be fast, effective and accurate with tight control over quality in order to get a drug ready for clinical trials. In this webinar, Mark Parry, Technical Director, Intertek Melbourn, describes the strategies required for rapid repurposing for inhaled delivery, discussing considerations whilst mitigating anticipated challenges.
  • Video VIDEO - Analysis and Characterization of mRNAs for Therapeutic and Vaccine Development

    Development of Next-Generation of mRNA-Based Vaccines & Therapeutics: With a combination of state-of-the-art analytical technology and a long history of working with advanced pharmaceutical development, our experts in Total Quality Assurance assist you in the drug development process. Get in touch with us today to learn how we can help you ensure the quality, efficacy, and safety of your mRNA therapy.
  • Video WEBINAR - Characterization and quantification of known & unknown substances by NMR

    Structure elucidation and quantification of unknown species is one of the biggest challenges during development of analytical methods for routine quality control. The advantage of the NMR is the relatively simple and robust sample preparation combined with unique selectivity which often differs from those of chromatographic techniques. In many cases, matrix components and target species will show NMR signals with opposite shifts which enables the characterization of the targets directly in the sample mixture. In this webinar, we will explain how quantitative NMR can be used as a powerful tool for characterization of isolated unknowns or even complex mixtures of different compounds. Our expert will explain the advantages of the NMR method in detail with typical examples from routine analysis.
  • Video WEBINAR - Biocompatibility - The Importance of Extractables & Leachables Testing

    To ensure patient safety, precise knowledge about potential contamination associated with medical device materials is critical. For this reason, a robust chemical characterization is the first and mandatory step of any biocompatibility study which is performed according to the most recent version of the ISO 10993 guidance. With increasing complexity of medical devices and combination products, the risk of leachables being introduced into the body increases significantly. Depending on the type/class of device, application scenario and contact time, extractables and leachable studies can be divided in different sub-steps to build a comprehensive understanding of the related risks. 
    During this webinar, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, will provide an analytical strategy for e/l screenings with a focus on the problems which may occur when targets above the analytical evaluation threshold are detected.
  • Video WEBINAR - Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

    Structural integrity of protein-based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. Multiple biophysical methods employing spectroscopic and calorimetric tools can be used for analysing Higher Order Structure (HOS). This presentation from Intertek’s biophysical expert, Anshuman Shukla, details different biophysical techniques, their application and usefulness in a regulatory setting.
  • Video WEBINAR - Development of a Quality Control Strategy for Vaccines

    Vaccines represent a diverse class of products within the pharmaceutical industry. All are complex and present their own unique challenges not only in production but in the design and implementation of strategic characterisation and quality control programs. The highest levels of safety and efficacy should be ensured through application of phase specific validated analytical methods.


    In this webinar, our expert, Ashleigh Wake, describes how to build strategic quality control programs, with a focus on mRNA and DNA-based vaccines, which are product and phase specific covering the need for specialist, bespoke analytical approaches for these highly complex products.
  • Video WEBINAR - A Comparison of qPCR and ddPCR Methods for Residual DNA Analysis

    In this webinar our expert discusses our HEK293 and E.Coli  Residual DNA quantification assays comparing a quantitative PCR (qPCR) approach with a more recent digital droplet PCR (ddPCR) technique in terms of sensitivity and reproducibility as well as discussing technical challenges.
  • Video WEBINAR - Monitoring of Glycosylation Using Site Specific Approaches for Antibody-based Therapeutics

    Antibody-based Therapeutics N-linked glycosylation is a common post-translational modification on many antibody-based therapeutics, and has been linked to safety, stability and activity. Modification should therefore be monitored and controlled.


    During this webcast, our expert Michael Walker discusses peptide mapping and middle-up mass spectrometry as characterization techniques that give relative levels of different glycoforms at specific sites, and compares to more common methodologies of enzymatic stripping and fluorescent labelling.
  • Video VIDEO - Intertek Pharmaceutical Services - Bringing Quality and Safety to Life

    Intertek pharmaceutical contract laboratory services, regulatory guidance and supply chain assurance brings quality and safety to life to support your unique pharmaceutical or biopharmaceutical outsourcing requirements. Our scientists and regulatory experts work with you at every stage of development, providing consistently high quality and flexible GLP/GMP/GCP services that enable you to achieve a marketplace advantage. We enable our clients to navigate the challenges of new product development, scale up, manufacturing and market release through our specialist services including analysis, bioanalysis, formulation development, biologics characterization, inhalation development, regulatory consultancy, risk assessment, auditing and supply chain management solutions.
  • Video WEBINAR - Top 4 Steps to a Perfect Outsourcing Partnership

    This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme.
    In today's dynamic pharmaceutical landscape, companies look to focus on their core competencies and outsource for success. In this webinar, based on our 20+ years of experience providing flexible outsourcing strategies to the world's most innovative biopharmaceutical organisations, we share key learnings and discuss four key considerations for a perfect outsourcing partnership with a contract research organisation that helps to build mutual trust, optimise cost efficiencies, and mitigate risks:
    Communication What mode works for you? Focus on critical attributes Leverage partnership benefits
  • Video WEBINAR - Stability Studies and Outsourcing Solutions

    We share our thoughts on stability requirements for new drug substance or drug product, and steps required to ensure a robust stability program is implemented.
  • Video Take the Video Tour - Learn more about Intertek Pharmaceutical Services

    Watch our video tour now: https://youtu.be/XNRFUlrZcVQ

    Our scientists provide consistently high quality and flexible GLP/GMP/GCP services to enable you to navigate the challenges of new product development, scale up, manufacturing and market release.
  • Video GMP Stability Testing and Storage Capabilities

    With all ICH conditions storage and over 375,000L of capacity, including large scale walk-in units, bespoke storage cabinets and standard or ULT freezers, we provide end-to-end support for design, testing, storage and management for #pharma #stability studies. Learn More: https://www.intertek.com/pharmaceutical/analysis/stability/
  • Brochure Inhaled and Nasal Drug Development Services

    We focus on critical parameters impacting drug delivery efficacy to intended targets across all respiratory product classes (Nasal, DPIs, pMDIs, nebulizers..)
  • Brochure LEARN MORE: Shared Audits

    Our shared audits or joint audits for pharma or cosmetic supply chains provide a cost-effective solution for the audit of suppliers/subcontractors
  • Brochure LEARN MORE: Pharmaceutical Services

    Over the last 30 years, our network of GLP, GCP or cGMP laboratories and consultants have provided high quality custom services
  • Brochure Overview: GMP and CMC Pharmaceutical Laboratory Services

    Contract pharmaceutical laboratory services and outsourcing support to accelerate and optimise your drug development programs
  • Brochure LEARN MORE: ICH Stability Testing

    30 years’ experience in stability studies integrated with comprehensive understanding of the latest developments in regional, country and ICH guidance.
  • Brochure LEARN MORE: Extractables and Leachables Testing

    Our scientists conduct E&L analysis studies in accordance with regional guidance and nationally and internationally recognized standards
  • Brochure LEARN MORE: Biopharmaceutical Development Support Services

    Our thought-leaders have over 25 years’ experience in biopharma development support proteins, mRNA, mAbs, vaccines, ADCs, peptides, oligos, biosimilars +
  • Brochure LEARN MORE: Inhalation Drug Development Services

    Formulation development, reformulation, product characterization, method dev and validation, inhaler testing, device verification, IV BE, CMC support for NDAs +
  • Brochure OLIGONUCLEOTIDE THERAPEUTICS DEVELOPMENT SUPPORT SERVICE

    Oligonucleotide analysis and drug development support services from the initial characterisation and CMC through to long term quality control.
  • Brochure Stability Storage and Stability Testing

    With a network of ICH stability facilities in the UK, US and Australia, we offer extensive storage capacity and a range of conditions.
  • Brochure Bioanalysis Services

    30 years of experience in conducting regulatory bioanalytical studies, optimizing value for your programs.
  • Brochure Audit Report Purchase

    To meet growing demand for supplier information and greater detail about specific sites, our clients are increasingly requesting the purchase of audit reports
  • Brochure Shared Audits - Efficient auditing for your supply chain

    Rapid implementation and optimisation of your audit schedule, providing a ‘win-win’ solution
  • Brochure USP <1663> & USP <1664> EXTRACTABLES & LEACHABLES

    Assessment of extractables and leachables for pharmaceutical packaging and delivery systems, to assess interactions between drug formulations and materials
  • Brochure GENOTOXIC AND MUTAGENIC IMPURITIES ANALYSIS

    Genotoxic impurities analysis to assess and control DNA reactive mutagenic impurities in pharmaceuticals
  • Brochure Extractable and Leachables

    Extractables and leachables to quantify risks associated with leachable impurities from container closure systems for packaging human drugs, process equipment
  • Brochure Biopharmaceutical Services

    Comprehensive biopharmaceutical bioanalysis, analysis, characterization, and potency services
  • Brochure INHALED & INTRANASAL BIOLOGIC DRUG DEVELOPMENT

    Formulation strategies, testing, characterisation, stability, performance/release testing and clinical manufacturing capabilities for inhaled or nasal delivery
  • Brochure GLP/GCP Bioanalytical Services

    Bioanalytical Expertise from Preclinical to Commercialisation
  • Brochure ICH Storage and Stability Testing

    GMP Stability programs and ICH stability storage
  • Brochure Extractables and Leachables Expertise

    Over 30 years of E&L study expertise across all CCS formats
  • Brochure INHALED & INTRANASAL BIOLOGIC DRUG DEVELOPMENT

    Contract drug development expertise to accelerate your inhaled biomolecule to market
  • Brochure Inhaled and Nasal Drug Development Support Services

    Formulation, Device selection, Stability, Analytical, CTM and more from our COE for OINDP development
  • Brochure CELL AND GENE THERAPIES ANALYTICAL DEVELOPMENT SERVICES

    CMC Development Support, Characterisation, Stability and Quality Control Services
  • Brochure mRNA VACCINE AND THERAPEUTIC PRODUCTS ANALYTICAL DEVELOPMENT SERVICES

    CMC Development Support, Characterisation, Stability, and Quality Control Services
  • Brochure OLIGONUCLEOTIDE THERAPEUTICS DEVELOPMENT SUPPORT SERVICES

    CMC Development & Delivery Technologies Support, Characterisation, Stability and Quality Control Services
  • Brochure Biologics Drug Development Support Services

    30 years of biologics drug development support services, characterization, E&L, stability and drug delivery support (OINDP and other formats)
  • Brochure Intertek Pharmaceutical Services

    Contract pharmaceutical and biopharmaceutical GLP/GCP/GMP laboratory services, supply chain audits and regulatory guidance
  • Video VIDEO - Intertek Melbourn: Inhaled and Nasal Drug Product Development Expertise

    Over the past 30 years, Intertek Melbourn, UK, has provided clients with testing and development services for orally inhaled and nasal drug products, including method development/validation, stability, CMC support, formulation development, repurposing, and clinical manufacturing.

Frequently Viewed Together

  • Product Analytical Services

    Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
  • Product Core Technologies and Services

    • API / GMP Manufacturing • Rapid Process Development, Flawless Upscaling, and Economy of Scale-Production  • Simulated-Moving Bed (SMB) Chromatography  • Heterocyclic, Hazardous and Malodorous Chemistries • Organometallic and Cryogenic Chemistry • Transition-Metal Catalysis • High-Pressur...
  • Product UV Light Blocking Tyvek Equipment Covers

    UV Light Blocking Tyvek Equipment Covers are designed to keep cleaned pharmaceutical equipment and supplies clean and protected from external sources of contamination while also providing in-process protection to light sensitive biotech products.
  • Product Formulation Development

    Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
  • Product Analytical Services

    Actylis performs routine and non-routine analytical testing for various industries, in support of manufacturing processes, QA/QC functions, R&D projects, and environmental applications. Leveraging state-of-the-art instrumentation, extensive knowledge base, as well as internal, cross-functional competen...
  • Product Qualicaps® Inhalation-grade capsules portfolio

    With nearly +125 years of capsule manufacturing experience, and the introduction of several capsule innovations to the pharmaceutical market, specifically in the field of inhaled drug delivery, Qualicaps® offers a broad portfolio of capsules specially designed for inhaled drug delivery, with superior a...
  • Product PHARMACEUTICAL ANALYSIS DEPARTMENT

    Spark-Lab Pharmaceutical Analysis Department performs routine analyses with a special emphasis on determination of excipients, such as:

    • Quantitative determination of sorbitol, glycerol, maltitol, mannitol in liquid forms based on our own method; • Quantitative determination of glucos...
  • Product Walk in Cooling Cabinet.

    The Walk-In Cooling Cabinets / cold rooms are designed according to ICH guidelines, WHO, MCA and USFDA requirements to maintain uniform conditions. They are superior in airflow distribution, temperature control technology, cabinet construction and are manufactured as per cGMP regulations.
    Biggest Walk...
  • Product Development Sciences

    Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale...
  • Product Laboratory Services

    Laboratory Services
    Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-​related products. In addition to developing and validating analytical methods, batch-...
  • Product ADAPTEK® TECHNOLOGY

    ADAPTEK® TECHNOLOGY is the general name for our 4 international patents and expertise in nanotechnology and controlled release systems.This is a transversal technology that allows to develop customized biopolymeric nanohydrogels, allowing the load with different API (drugs, vitamins, growth factors, etc.)....
  • Product Complex drug formulation

    We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...
  • Product Analytical Services

    Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...
  • Product Hi-End Resource On Demand Solutions

    Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....
  • Product Analytical services - OEL: 50 ng/m3

    • Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...
  • Product Kemwell Biopharma

    SERVICES Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufa...
  • Product Analytical Services

    With 55+ years of experience, our expert teams develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon an extensive range of analytical technology, combined with a wealth of analytical knowledge, we can add real value to your drug development and commercialisation programs....
  • Product Biologics

    End-to-end development and manufacturing capabilities across different therapeutic modalities and the entire product lifecycle

    Cutting-edge technology platforms for high yielding cell lines (both mammalian and microbial) and high concentration formulations


    Integrated and flexible drug sub...
  • Product Biologic drug substance CDMO services

    From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
  • Product GALENIC DEVELOPMENT

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

    GALENIC DEVELOPMENT
    • Preformulation studies.
    • Design and galenic develop...
  • Product QACS Pharmaceutical services

    QACS Lab is GMP/GLP certified and provides contract laboratory testing for Pharmaceuticals. Methodologies stay in accordance with EMA & FDA. QACS is equipped with Microbiological - Chemical - Molecular - Packaging laboratory premises to provide variety of Pharmaceutical testing solutions &...
  • Product 1 GHz NMR

    New Evo 1 GHz NMR fits in 1 story building, uses 70% less helium. Ideally suited to characterise complex molecules such as RNA, oligonucleotides, peptides, antibodies and more!
  • Product Elemental Impurities

    Brightlabs has in-house validated methods for the analysis of elemental impurities in accordance to ICH-Q3D. Brightlabs has a unique approach for ICHQ3D, which guarantees quick turnaround times at reduced cost
  • Product Consulting: Quality Management System

    Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
  • Product Bioequivalence tests for topical drugs

    We are a GLP lab specialist in vitro permeation testing, including the bioequivalence tests under the EMA draft guideline. We support pharmaceutical companies through bioequivalence studies. Visit our booth and find out more about our R&D dedicated to this topic.
  • Product Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • Product RoSS® Shell: Protection of single-use bags

    Protect your single-use bioprocess containers: RoSS® Shells - abbreviated for Robust Storage and Shipping - reduce product loss towards 0%. Compatible with all available sizes and types of single-use bags, RoSS enables standardized and scalable end-to-end process solutions for fluid management and col...
  • Product VetaFilmTM - Veterinary Oral Film Technology

    VetaFilm™ is our proprietary veterinary oral film technology that provides significant market opportunities to improve drug delivery for companion animals. VetaFilm™ research and development services and veterinary oral films provide: • Dose placed directly on oral mucosa or on their f...
  • Product Development Service

    Lomapharm GmbH provides wide range of services which includes development service. It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev...
  • Product Analytical Services & Methods

    CritiTech provides a suite of material characterization and analytical services to support our clients drug development projects from proof-of-concept through cGMP production. Our testing data and documentation is reviewed by experienced technical and quality staff to ensure it can be used to support regul...
  • Product FPFs

    • Genexol®PM Inj.(Paclitaxel)   • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...
  • Product Biosimilars Portfolio

    • Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing...
  • Product Biotest Human Serum Albumin

    • Human Serum Albumin for the biotechnology and pharmaceutical industry • We offer a human serum albumin (HSA) product that complies with the regulatory requirements of multiple health authorities.   • It is manufactured in a GMP compliant, state-of-the-art manufacturing plant and supplied und...
  • Product Wasdell Laboratory Services

    By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...
  • Product Analytical Services

    ChemCon's analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership:...
  • Product Analytical services

    Analytical services 

    In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:

     

    GMP for excipients, risk assessment...
  • Product SOFTGELS

    At Softigel, we offer much more than traditional softgels, including everything from a single unit dosage form, to multiple delivery systems in a single dose. Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS Classes II, III and...
  • Product Biotherapeutics

    To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.

    Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...
  • Product Stability Testing

    From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
    When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...
  • Product Quality - QEdge - Enterprise Quality Management Suite

    Sarjen Systems' QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
    • Process Control • Document Control & Issuance • Training Management System • Ve...
  • Product ULT Freezer

    FARRAR's Ultra-Low Temperature Freezer is SNAP/EU F-gas-compliant, offering low energy consumption with a low global warming potential (GWP) natural hydrocarbon refrigerant (R290/R170). With a temperature range of -50°C to -86°C with
  • Product Dry Powder Inhalation (DPI)

    Catalent provides development and manufacturing services for Dry Powder Inhaler (DPI) capsules.  With support for clinical- and commercial-scale, the team can handle projects at any stage. Catalent's Boston-area DPI capsule manufacturing facility is equipped with modern, top-tier encapsulation and...
  • Product Facility & Process Validation Testing

    Manufacturing facilities and processes can be a primary source of product contamination. Nelson Labs offers a range of services to assess these manufacturing environmental conditions, in addition to water system validations, raw material screening and residual manufacturing material tests.
  • Product PharmaLex

    PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical deve...
  • Product High-potent Dosage Forms

    We have the experience, expertise, and facilities at Sever Pharma Solutions to safely work with your high-potent substances. This includes manufacturing products containing APIs that are ranked in the highest occupational exposure bands (OEB) up to and including OEB6.

    Our focus on safety starts ...