20
May
2025
Intertek Analytical Services
Exhibitor at CPHI Americas 2025 stand 412
About Us
Categories
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GB -
2015On CPHI since
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4Certificates
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1000 - 4999Employees
Company types
Primary activities
Contact info
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Intertek Pharmaceutical Services, Hexagon Tower, Crumpsall Vale. off Delaunays Road, M9 8GQ, Manchester, United Kingdom
Event information
CPHI Americas 2025
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20 May 2025 - 22 May 2025
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Pennsylvania Convention Center, Philadelphia
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Visit us at stand 412
Products Featured at CPHI Americas 2025
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Product Analytical Method Development and Validation Supporting Drug Development
Supporting Your Analytical Method Lifecycle
Intertek offers cost-effective strategic approaches to analytical method lifecycle management, which combines method development, improvement, qualification, validation, method transfer to and from client laboratories, and maintenance related to GMP producti... -
Product Biopharmaceutical Development Support Services
Fundamental to your biopharmaceutical chemistry, manufacturing and controls (CMC) development, you will need detailed analytical characterisation data to satisfy regulatory requirements. Our experts strategically deploy orthogonal protein analysis approaches that address key molecular and biological charac... -
Product cGMP Pharmaceutical Quality Control Testing
QC testing of pharmaceutical raw materials to international pharmacopoeia specifications has become a specialty of Intertek. With our knowledge of analytical chemistry and our vast range of instrumental techniques, we can undertake the vast majority of the chemical tests listed within the international pha... -
Product Cleaning Validation Analysis Support for Pharma Production
Our analytical scientists provide cleaning validation analysis from our GMP compliant laboratories. We ensure that fit-for-purpose analytical methods are specific for the substances being assayed and suitable to detect contaminants at the specified ARL for an appropriate level of cleanliness (sensitivity).... -
Product Elemental Impurities Testing
Our elemental impurities experts and toxicologists can help you to develop a compliance strategy to achieve successful implementation of ICH Q3D requirements. Intertek's GMP laboratory services teams facilitate the process through the design of tailored analytical programs based on wide experience of pharm... -
Product Extractables and Leachables Studies
Regulatory agency expectations are continually evolving with ever more stringent requirements for the evaluation of drug product packaging associated with each new product. Our extractables and leachables scientists based at our GMPscientists conduct E&L analysis studies in accordance with regional g... -
Product Formulation Development Contract Services
Our drug product formulation development teams offer design and optimisation of formulations for powders, capsules, liquids and solids, semi-solids, inhaled, nasal, nebulised, pressurised and topical drug formulations. We provide focused understanding from an early stage of development tailored to your new... -
Product GCP/GLP Bioanalysis Services
In our state-of-the-art facilities, we provide GLP/GCP method development, validation, method transfer, sample analysis and pharmacokinetic and toxicokinetic support, along with automated data collection and reporting systems. Over the past 20 years, we have supported the development of pharmaceuticals, bi... -
Product Genotoxic Pharmaceutical Impurities Analysis
Our GCP/GLP/GMP compliant laboratories provide genotoxic impurity testing services to detect and evaluate the potential of GIs for your API and/or drug substances which can support your product development from an early stage to market release. With scientists who are adept at method development and valida... -
Product GMP and CMC Pharmaceutical Laboratory Services
We provide regulatory-driven, phase-appropriate, CMC laboratory and GMP pharmaceutical laboratory services. Our expertise ensures sufficient information for your Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings. This is achieved through analysis... -
Product ICH Pharmaceutical Stability Testing and Storage
With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlled and monitored... -
Product ICH Stability Testing, Storage & Program Management
Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every location. We have 24-hour alarm systems at all sites with dedicated teams on... -
Product Inhalation Drug Product Development Services
With 30 years of experience in supporting development of inhalation drug products for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, device verification testing,... -
Product Inhaled Biologic Drug Development
Intertek has over 30 years’ experience in biologics characterisation, from small peptides up to monoclonal antibodies and conjugated species, and contract testing, formulation and clinical manufacturing services supporting orally inhaled and nasal drug product development. The Intertek Centre of Excellence... -
Product Medical Device Testing
Our medical device testing experts provide scientific solutions for wound care, stents, cardiovascular implants, dermal fillers, orthopaedic implants, bone cement, biomaterials, catheters, in vitro diagnostics, combination products such as pre-filled syringes or inhaled drug products, and dental or surgica... -
Product Nasal Drug Product Development and Formulation
Nasal Drug Development Expertise
Our team flex their 30 years of inhaled or nasal drug development experience to help you overcome development challenges for nasal solutions, suspensions and dry powders, providing the critical performance and quality testing you need for successful product development... -
Product Nebulised Drug Product Development Services
We have been supporting clients’ product development for over 30 years across all classes of inhaled and nasal delivery technologies including nebulized therapeutics. We provide expert OINDP formulation development, product performance testing and analysis, in vitro bioequivalence studies, stability, produ... -
Product Nitrosamine Impurity Testing
At Intertek we also offer a GC-MS/MS approach which has allowed our experts to achieve excellent LOD and LOQ values. Overall, GC has proved extremely useful for some difficult projects, helping us to present an alternative and successful route to avoiding challenges associated with Liquid Chromatography co... -
Product Pharmaceutical Analysis Contract Services
Whilst your organisation focuses on your core business goals, you will need to select a contract analytical services partner with a strong history of delivering regulatory compliant testing to a consistently high standard. Our contract analysis services are focused on supporting product development, GMP ma... -
Product Pharmaceutical Dissolution Testing
Pharmaceutical dissolution testing plays a key role in drug development and across the drug product lifecycle. In early phase development, dissolution helps to establish the dissolution mechanism, in later stages (stage II to III) dissolution testing helps to drive insight into key formulation or process p... -
Product Pharmaceutical Impurity Analysis and Identification Testing
Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) that can support your product development from an early stage and across the lifecycle of your drug product. Our scientists are adept at method routinely overcome... -
Product Residual Solvents and Organic Volatile Impurities (OVI) Analysis
Our pharmaceutical impurities analysis team provide expert determination and identification of residual solvents, delivered from our GMP compliant laboratories, to help you to ensure that residual solvents have been reduced to acceptable levels in drug products, drug substances and excipients. Often it is ... -
Product Supply Chain Auditing
Our network of senior qualified auditors, who are located all around the world, are proud to support our global pharmaceutical, consumer healthcare and cosmetics clients delivering a suite of flexible auditing solutions which are designed to exactly meet the challenges that your business faces today.
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Product USP 232 and 233 Pharmaceutical Elemental Impurity Testing
Your USP Chapter 232/233 Testing Partner
We offer expert GMP elemental impurity analysis services according to USP General Chapter <232> and USP Chapter <233> which are Good Manufacturing Practice (GMP) compliant and are conducted in accordance with these USP chapters to support your raw ... -
Product Vaccine Characterization, Delivery and Bioanalytical Support
Our vaccines development experts provide a suite of services supporting the analysis, delivery, quality control of process and batch release samples and stability studies. We have support the development of a range of vaccines including mRNA, protein, glycoprotein, DNA, carbohydrate, lipopolysaccharide, li... -
Product Intertek Pharmaceutical Services
Intertek's pharmaceutical contract laboratory services, regulatory assistance, and supply chain assurance deliver quality and safety to meet your unique pharma and biopharma outsourcing needs. We bring quality and safety to life!
With our pharmaceutical experts working with you at every ... -
Product Biopharmaceutical Characterisation and Testing Services
Characterization and testing of biopharmaceuticals: Using our expert's insight into a biologic's structure, physicochemical properties, potency, and impurity profile, we help you meet your development milestones.
A range of expertise is available, including assessment of structure... -
Product Pharmaceutical Auditing Services
Auditing services for the pharmaceutical industry: Our pharmaceutical audits are conducted in accordance with the relevant regulatory texts or standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufactu... -
Product Inhalation Drug Product Development Services
Services for the development of inhalation drugs: Our team have over 30 years of experience supporting our clients' product development for orally inhaled or nasal drug products (OINDP). This includes formulation, stability, testing, product performance testing, in vitro bioequivalence studies, CMC... -
Product Drug Stability Testing and ICH Storage Outsourcing
Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every locatio... -
Product GMP and CMC Laboratory Services
Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres of excellence for method development and validation, analysis, stability s... -
Product Oligonucleotide Analytical Development Services
Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch r... -
Product Bioanalytical Services (GLP/GCP)
Services for Bioanalysis (GLP/GCP): In our state-of-the-art facilities, we provide GLP/GCP method development, validation, method transfer, sample analysis and pharmacokinetic and toxicokinetic support, along with automated data collection and reporting systems. Over the past 20 years, we have supported... -
Product Development and Validation of Analytical Methods
Analytical methods development and validation: Our method development scientists work with a broad range of products, methods, and analytical technologies (chromatography, mass spectrometry, spectroscopy, biophysical analysis, bioanalytical techniques, etc.) to ensure that the method will meet its int... -
Product Formulation Development including Inhaled Products
Inhaled products and formulation development: The development of drugs using experimental design approaches with integrated stability testing and storage is available from us. Our formulation specialists can provide a wide range of formulations in a timely and cost-effective manner in order to identify t... -
Product Nasal Drug Development
Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laborato... -
Product Extractables and Leachables Testing Services
Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l... -
Product Bispecific Antibody Characterisation
Characterisation of bispecific antibodies supporting regulatory considerations for therapeutic development. Our scientists offer BsAb characterisation, with a focus on monitoring relevant CQAs. We can help you to demonstrate consistency or comparability of manufactured batches or as release tests for clin... -
Product Inhalation Product Analysis and Testing
Inhalation product analysis and testing services include particle size and droplet characterization, delivered dose testing, as well as aerodynamic particle size analysis – for pressurized metered-dose inhalers (PMDI), dry powder inhalers (DPI), nebulizers, and soft mist inhalers. Our Good Manufacturin... -
Product Nitrosamine Impurity Testing
Nitrosamine - testing for its impurities: Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) continue to be an area for concern as highlighted by the US FDA and other regulatory authorities. At Intertek we believe flexible solutions are the way forward to overcome technical challenges and ac... -
Product Antibody / Monoclonal antibody therapeutics services
Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, ... -
Product Gene Therapy Characterisation and Release Testing
Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a... -
Product Clinical Trial Supplies Manufacturing Services
Services for manufacturing clinical trial supplies: To meet your supply needs for investigational medicinal products (IMP) or investigational new drugs (IND) for clinical trials around the world, we provide GMP clinical trial materials manufacturing services. Integrated with raw material testing, ... -
Product mRNA Characterisation and Analysis
Characterization and analysis of mRNA supporting vaccine and therapeutic development, including assessing clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug product to help you confidently assess batch to batch manufa... -
Product cGMP Cell-based Bioassays
Cell-based bioassays that comply with cGMP: Using a variety of techniques, including cell-based assays, ligand and receptor binding assays, and flexible multiple assay approaches – our potency testing experts offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1)... -
Product Analytical Research and Development Services
Services for analytical research and development: As your organization focuses on core business goals, you'll require a partner who has a history of providing consistently high-quality regulated compliance testing. Our team are focused on supporting product development, GMP manufacturing and distributio... -
Product Protein Aggregation Analysis and Characterization
Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel... -
Product Genotoxic Impurities ID and Quantification
Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity l... -
Product Elemental Impurity Testing ICH Q3D
Testing for elemental impurities ICH Q3D: To successfully implement ICH Q3D requirements, our experts in elemental impurities and toxicology can help you develop a compliance strategy. We can provide screening studies and data to aid risk assessment, if this does not already exist, or develop and valida... -
Product Biosimilars Testing Services
Testing services for biosimilars: Our biosimilar analytical comparability programs provide highly relevant data for early stage characterisation and later stage comparison. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the ICH Q6B. Programs encompa... -
Product Biomarker Assays and Validation
Validation of biomarker assays: Our diverse range of analytical platforms supports biomarker analyses including ELISA, flow cytometry, cell-based assays, multiplex ECL platforms, and high sensitivity measurements using QuanterixSimoa HD-X Analyzer™ measurement instruments. Our dedicated biomarker assay... -
Product Liposomal Drug Delivery Technologies Development Support and Analysis
Liposomal drug product characterisation according to the FDA CMC guidance to support your new drug application or biologics license applications. Including:
• Physicochemical parameters determined to be CQAs (e.g. particle size, size distribution, zeta-potential and physical stabi...
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