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

  • Products
    0
  • Companies
    0
  • Articles
    0
  • Events
    0
  • Webinars
    0
Read more about CPHI

Data Sciences

Data Sciences
Product Description

You need data rapidly to make crucial decisions during a study. Faster data means we can provide our customers with earlier interim data and interim PK reports for on-study dosing and formulation decisions.
We understand on-study changes to early phase study designs and dosing are frequent and so our study strategy for study database design and reporting is built around flexibility and rapid implementation. We use eSource data collection procedures in our clinical units and a joint eSource/eCRF database. Data are available in the study database within hours of collection, ready for remote sponsor access.

- Data Management and Database Programming Statistics and Statistical Programming
- Pharmacokinetics
- Medical writing
- Standardizing study data with CDISC
- Statistics, Pharmacokinetics and Scintigraphy

 


Read more Show less

QUOTIENT SCIENCES LIMITED

  • GB
  • 2017
    On CPHI since
  • 500 - 999
    Employees
Company types
Academic/Research
Consultancy
Contract Service
Manufacturer/Innovator
View company profile
Categories
more categories Show less
Specifications
  • Supplied from
    United Kingdom; United States
More specifications Fewer specifications
Sales Markets
Show more Show less

QUOTIENT SCIENCES LIMITED

  • GB
  • 2017
    On CPHI since
  • 500 - 999
    Employees
Company types
Academic/Research
Consultancy
Contract Service
Manufacturer/Innovator
View company profile

More Products from QUOTIENT SCIENCES LIMITED (16)

  • Drug Substance

    Product Drug Substance

    Our streamlined approach to developing drug substance has been shown to reduce manufacturing costs by 50% from preclinical to Phase I.  To best support our customer’s needs, we have made significant investments in technologies and equipment to meet the increasing demand for complex small-scale dr...
  • Formulation Development

    Product Formulation Development

    Quotient Sciences has almost 30 years of experience developing a breadth of pharmaceutical formulations across a range of indications. Our innovative approach to formulation development integrates drug product development with clinical evaluation, combined with our experience with over 1,000 molecules at a...
  • Clinical Trial Manufacturing

    Product Clinical Trial Manufacturing

    Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient offers a clinical trial manufacturing, testing and certification service designed to meet your individual requirements. Our innovative method of building integrated GMP and GCP programs ...
  • Commercial Manufacturing

    Product Commercial Manufacturing

    Quotient Sciences is a global player in commercial drug product manufacture of small molecule products for niche therapies including oncology and orphan drugs. Our commercial manufacturing facility located in Philadelphia is designed to handle your high-potency compounds.
    Our commercial batch ...
  • Clinical Pharmacology

    Product Clinical Pharmacology

    When you are looking for a partner who is dedicated to Phase I trials and early clinical development, rely on Quotient Sciences for the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. We accelerate your molecule from first-in-human to proof-of-concept...
  • Bioanaysis

    Product Bioanaysis

    Delivering rapid bioanalytical data in discovery – preclinical – clinical. Bioanalysis is a critical step in the drug development process.  At Quotient, we are experts in the development, validation, and application of bioanalytical assays.  
    Our dedicated team of bioanalytical chemists...
  • Drug Development Consulting

    Product Drug Development Consulting

    Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch.

    Our cons...
  • Global Clinical Trial Supply

    Product Global Clinical Trial Supply

    Accelerate your timeline, with flexible, on-demand delivery. We’ll design and develop your packaging, labelling and distribution strategy for Phase I, Phase II and Phase III clinical studies, so you’ll no longer have to worry about the challenge of getting your drug product to multiple sites in time fo...
  • Pediatric Development

    Product Pediatric Development

    Pediatric formulation and product development

    The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. Quotient Sciences has extensive knowledge and capabilities that enable us to provide you...
  • Orphan Drug Development

    Product Orphan Drug Development

    Accelerating orphan drug development from candidate selection to commercial manufacture and supply.

    With over 300 million people worldwide living with identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of great interest in the pha...
  • Inhaled Drug Development

    Product Inhaled Drug Development

    Quotient has a 30 year track record in the development and manufacturing of inhaled drug products. We have experience across a range of drug delivery platforms including dry powder inhalers (DPIs) and solutions/suspensions for inhalation. With integrated capabilities and vast knowledge of nasal and pu...
  • Translational Pharmaceutics - Integrated Programs

    Product Translational Pharmaceutics - Integrated Programs

    Translational Pharmaceutics® accelerates drug development by integrating formulation development, real-time manufacturing and clinical testing. The platform is unique to Quotient Sciences and has been used over the last decade by global pharmaceutical and biotech companies across over 400 drug programs. qq...
show all 16 other products

QUOTIENT SCIENCES LIMITED resources (25)

  • CPHI Milan 2024: Excerpts from the Exhibitors

    News CPHI Milan 2024: Excerpts from the Exhibitors

    After another successful year of bringing the pharmaceutical community together at CPHI Milan in October, hear direct from the exhibitors on why the event is so important for them and the industry as a whole. 
    22 Nov 2024
  • Formulation Development at Quotient

    Technical Data Formulation Development at Quotient

    Quotient Sciences has almost 30 years of experience developing a breadth of pharmaceutical formulations across a range of indications. Our innovative approach to formulation development integrates drug product development with clinical evaluation, combined with our experience with over 1,000 molecules at all stages of drug development. 
  • Quotient Sciences acquires UK-based CDMO Arcinova

    News Quotient Sciences acquires UK-based CDMO Arcinova

    With over 40 years of experience and 160 employees, Arcinova provides drug substance, drug product and bioanalysis services to over 200 pharma and biotech customers worldwide
    9 Mar 2021
  • Clinical Pharmacology at Quotient

    Technical Data Clinical Pharmacology at Quotient

    When you are looking for a partner who is dedicated to Phase I trials and early development,rely on Quotient Sciences. 

    We accelerate your molecule from first-in-human to proof-of-concept,helping you make critical decisions earlier. 
    Whatever clinical pharmacology study you require, you can expect a fully integrated program from study design to data reporting.

  • News Quotient Sciences Completes Million Dollar Pharmacy Expansion at Miami Clinic

    Miami, FL/June 22, 2020 - Quotient Sciences, a global pharmaceutical development, clinical and commercial manufacturing organization, announced today the completion of a $1 million dollar pharmacy and laboratory expansion at their Miami, FL clinical pharmacology facility. 


    The expanded pharmacy capabilities offer customers a quick and cost-effective way to start clinical testing, without the need for extensive CMC investment or API consumption at this early stage of development.
    8 Sep 2020
  • Global Formulation & Manufacturing Capabilities

    Technical Data Global Formulation & Manufacturing Capabilities

    With over 30 years’ experience, Quotient Sciences provides full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.
  • Quotient Sciences and CytoAgents Accelerate Potential Treatment for COVID-19 Cytokine Storm

    News Quotient Sciences and CytoAgents Accelerate Potential Treatment for COVID-19 Cytokine Storm

    Collaboration Expedites Human Clinical Trials for COVID-19 Drug Candidate. A collaboration to accelerate the development of a lead COVID-19 drug candidate into human clinical trials was announced today [April 28, 2020] by Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, and CytoAgents, Inc. a privately help biotechnology company focused on the development of pharmaceutical products for treatment of infectious diseases.
    4 Sep 2020
  • Clinical Trial Manufacturing at Quotient

    Technical Data Clinical Trial Manufacturing at Quotient

    Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient offers a clinical trial manufacturing, testing and certification service designed to meet your individual requirements. 

    Our innovative method of building integrated GMP and GCP programs provides you with a streamlined, flexible approach to drug product supply that reflects your clinical study design and timeline. 


    We understand the time and cost pressures you face during early phase evaluation and work with you to ensure a rapid, seamless path from development to clinical trial supply.

  • News ANA Therapeutics and Quotient Sciences Announce Partnership to Manufacture Niclosamide Drug Candidate as a Potential Treatment for COVID-19 Collaboration

    ANA Therapeutics, a Silicon Valley-based biotech startup, and Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, today announced a partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which they are developing as a potential treatment for COVID-19.
    19 Aug 2020
  • Commercial Manufacturing at Quotient

    Technical Data Commercial Manufacturing at Quotient

    Pharmaceutical commercial manufacturing - Quotient Sciences is a global player in commercial drug product manufacture of small molecule products for niche therapies including oncology and orphan drugs. 
    Our commercial manufacturing facility located in Philadelphia is designed to handle your high-potency compounds.
  • Pediatric Development at Quotient

    Technical Data Pediatric Development at Quotient

    Pediatric formulation and product development
    The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. 

    Quotient Sciences has extensive knowledge and capabilities that enable us to provide you with a unique integrated pediatric development solution.

  • Taste Masking at Quotient

    Technical Data Taste Masking at Quotient

    Many drug substances are extremely bitter or have other aversive attributes,which can make developing palatable drug products extremely challenging.This is a common problem seen in medicines spanning all therapeutic areas,from antibiotics and painkillers to antihistamines and decongestants. The careful design and development of formulated oral drug products is key to ensuring patient acceptability and compliance for achieving the desired clinical outcomes.
  • 505(b)(2) Product Development at Quotient

    Technical Data 505(b)(2) Product Development at Quotient

    Are you developing a new dosage form for an existing drug? 

    Do you need to explore a different route of administration?

    Quotient has significant experience in 505(b)(2)product development and can support you in efficiently turning your innovative ideas into successful products.Over the past several years, the FDA’s 505(b)(2)regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules
  • Translational Pharmaceutics - a Quotient Innovation

    Technical Data Translational Pharmaceutics - a Quotient Innovation

    Translational Pharmaceutics® accelerates drug development by integrating formulation development, real-time manufacturing and clinical testing. The platform is unique to Quotient Sciences and has been used over the last decade by global pharmaceutical and biotech companies across over 400 drug programs.
  • PBPK Modelling and Simulation at Quotient

    Technical Data PBPK Modelling and Simulation at Quotient

    Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. 

    Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies. 


    Whether working in a consultancy relationship or as part of an integrated program of work, our PBPK expertise is underpinned by our unique and extensive experience in pharmaceutics, biopharmaceutics, DMPK and clinical research.
  • Pre-formulation & Material Sciences at Quotient

    Technical Data Pre-formulation & Material Sciences at Quotient

    Providing expertise to support pre-formulation development

    Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
  • Compounding and GMP Manufacturing for Product Supply at Quotient

    Technical Data Compounding and GMP Manufacturing for Product Supply at Quotient

    Quotient Sciences provides integrated pharmacy compounding, formulation, GMP manufacturing and clinical testing solutions to help clients achieve their proof-of-concept (POC) milestone quickly, saving them precious development time and money.  

    Begin your First-in-Human (FIH) Phase I testing with a fit-for-purpose, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, all within one organization.
  • Inhaled Product Development at Quotient

    Technical Data Inhaled Product Development at Quotient

    With more than 30 years’ experience, Quotient is a leader in the development, manufacture and assessment of inhalation products, helping clients to accelerate molecules from first-in-human through to proof-of-concept. 

    Our integrated capabilities and vast knowledge encompasses pre-formulation sciences, formulation development, device evaluation, clinical trial manufacturing and the clinical assessment of a variety of inhaled formats for nasal and pulmonary delivery.
  • High Potency Handling at Quotient

    Technical Data High Potency Handling at Quotient

    High Potency Drug Development & Manufacturing

    Highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly common in drug development pipelines, especially in the oncology sector, as researchers search for therapies with greater selectivity and pharmacological activity. However, HPAPIs present additional CMC challenges due to the containment requirements to protect both the operators and manufacturing facilities. Their production processes may also require greater precision and control due to the very small quantities of drug present in the final dosage form.
  • Human ADME Studies at Quotient

    Technical Data Human ADME Studies at Quotient

    Whatever your requirements, Quotient Sciences can support you in the generation of clinical metabolism data for your drug development program and for NDA, MAA and global regulatory filings.
  • First-in-human to Proof-of-Concept at Quotient

    Technical Data First-in-human to Proof-of-Concept at Quotient

    Quotient Sciences’ Translational Pharmaceutics® approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.

    How? Quotient’s Translational Pharmaceutics® platform integrates formulation development, real-time adaptive GMP manufacturing and clinical testing so that drug product manufacture occurs immediately prior to dosing.Each manufacture of drug product is therefore conducted in response to emerging clinical data. This approach delivers significant benefits to the development team.
  • Spray Drying at Quotient

    Technical Data Spray Drying at Quotient

    Overcoming poor drug solubility and bioavailability challenges

    Drug solubility has a significant impact on bioavailability. 70% of new chemical entities (NCEs) suffer from low aqueous solubility that can result in failure during clinical testing due to poor bioavailability. Selecting an appropriate drug formulation is imperative to the success of the program.
  • Project Management at Quotient

    Technical Data Project Management at Quotient

    Project Management at Quotient – A True Partnership
    Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.
  • John McDermott, Quotient Sciences, discusses the unique benefits of Translational Pharmaceutics

    Video John McDermott, Quotient Sciences, discusses the unique benefits of Translational Pharmaceutics

    John McDermott, Executive Director, Drug Development Solutions - Quotient Sciences discusses Translational Pharmaceutics at CPHI Worldwide, and how a recent Tufts study has proven the significant savings and financial benefits for drug developers who use Translational Pharmaceutics.
    2020-09-17
  • Formulation Strategies for Poorly Soluble Molecules at Quotient

    Technical Data Formulation Strategies for Poorly Soluble Molecules at Quotient

    As the number of poorly soluble compounds continues to increase in the industry development pipeline, conventional formulation strategies may not be sufficient to achieve acceptable levels of solubility in the gastrointestinal tract and hence absorption into the systemic circulation. Scientists will need to utilize advanced formulation technologies to maximize oral bioavailability.

Frequently Viewed Together

  • Data Integrity Assurance

    Product Data Integrity Assurance

    Data is a fundamental part of any Life Science production cycle and has become a major concern for global regulatory authorities.Choose PQE and ensure patient safety and business continuity within the entire product life cycle.
  • Certified toxicological studies

    Product Certified toxicological studies

    Toxicological tests performed at the Lukasiewicz - IPO:
    -allow a toxicological evaluation of chemical substances contained in pharmaceutical products, veterinary medicinal products, plant protection products, food and feed additives, industrial chemical substances, etc.,

    -make it possi...
  • Formulation Development

    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.
  • TIM-2

    Product TIM-2

    The TIM-2, as part of the SurroGUT™ platform, is the dynamic in vitro model of the large intestine. The lower GI model, with its anaerobic compartment containing highly metabolic active intestinal microbiota, precisely mimics the physiological conditions of the colon in vivo. TIM-2 can simulate the pr...
  • Drug Product Manufacturing Service

    Product Drug Product Manufacturing Service

    Ardena offers services under brand pharmavize which includes drug product manufacturing service. It can manufacture various dosage forms, including: solutions and (nano-)suspensions, powder and granule filled capsules, semi-solid and, liquid filled capsules, topical products, tablets, modified-release prod...
  • Printed Pharmaceutical Literature

    Product Printed Pharmaceutical Literature

    CCL Healthcare’s printed literature options are designed to meet the regulatory, multilingual, and instructional demands of the healthcare packaging industry. Our wide range of high-capacity folded package inserts, outserts, padded inserts, booklets, glued pads, and more provide ample space for detailed le...
  • Preclinical Functional Neuroimaging

    Product Preclinical Functional Neuroimaging

    neuroPhINDr is our answer to the problem of low translational value of preclinical neuroimaging. With neuroPhINDr, we aim to shorten time-to-market, increase confidence in preclinical results and improve success rates in phase I trials. neuroPhINDr is a set of highly optimised and standardised protocols fo...
  • PharmaLex

    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...
  • Elitech Tlog 100EL Digital Temperature Data Logger Reusable Temperature ...

    Product Elitech Tlog 100EL Digital Temperature Data Logger Reusable Temperature ...

    Elitech Tlog 100EL Temperature Data Logger Reusable Ultra Low Temperature Recorder is used to monitor and record the temperature for foods, pharmaceuticals, dry ice and other products during their storage and transport, and in each stage of cold chain logistics, such as refrigerated contain-ers/ truck...
  • Clinical Research Solutions

    Product Clinical Research Solutions

    We design and execute clinical trials so new therapies get to market in the quickest and safest way possible. Full-Service Solution: We manage and execute full-service clinical trials across major therapeutic areas within medical device, diagnostics, drug, and biologic. Functional Service Provisi...
  • Authena L1VE

    Product Authena L1VE

    Single unit traceability in real time & eco-friendly from source to patient.
  • Clinical Data Mangement and Statistics

    Product Clinical Data Mangement and Statistics

    At ProRelix Research we are a team of experienced people who are well aware of 21 CFR, HIPAA, ICH GCP compliance to provide clinical data management services. Our statisticians have extensive experience in various phases of clinical trials and different therapeutic areas. Working on a project, our team see...
  • PharmaCircle Premium Database

    Product PharmaCircle Premium Database

    PharmaCircle provides the broad and deep global coverage, and powerful search and analysis tools needed to answer challenging questions so you can uncover new opportunities and make informed decisions. 
    Key content and capabilities include: 
    • Pipeline & Products Intelligence • D...
  • Microbiology

    Product Microbiology

    • Sterility Testing • Quality Control Release • Bioburden Testing • Method Suitability • Microbial Identification - MALDI-TOF • Bacterial Endotoxin Testing • Cytotoxicity • Environmental Monitoring • Biological Indicator Enumeration
  • Product Realization Without Boundaries

    Product Product Realization Without Boundaries

    As one of the largest contract development and manufacturing organizations (CDMO), the global footprint and rapid production capabilities of Phillips-Medisize allow customers to get to market faster and with more confidence. Combining Molex’s global scale in electronics with the design and manufacturing st...
  • InSyBio Personalization Test

    Product InSyBio Personalization Test

    InSyBio Personalization Test is a tailor made machine learning-solution solution for each company allowing customers to quantify the benefits from using particular nutraceutical, vitamin and other food products. Around this test we have developed and provide a complete set of services to differentiate prod...
  • Manufacturing Services

    Product Manufacturing Services

    At Sharp, we work closely with you to build an in-depth understanding of your goals, challenges and requirements before we begin our state-of-the-art manufacturing process. This enables us to tailor our clinical manufacturing services to meet your specific needs, making sure we deliver your product on time...
  • Formulation Development

    Product Formulation Development

    Quotient Sciences has almost 30 years of experience developing a breadth of pharmaceutical formulations across a range of indications. Our innovative approach to formulation development integrates drug product development with clinical evaluation, combined with our experience with over 1,000 molecules at a...
  • Biopharmaceutical Secondary Packaging

    Product Biopharmaceutical Secondary Packaging

    Any pharmaceutcal form

    Commercal & Clinical Supply
  • Medical Device Testing

    Product Medical Device Testing

    1) Physico-Chemical Testing of Raw Material & Finished Medical Devices2) Biocompatibility Testing of Medical Devices(As per ISO 10993-1:2018)
    3) Biological Testing of Raw Material of Plastic, Rubber,Silicone, Polymers, etc.(As per IP / BP / EP / JP / USP)
    4) Microbiological Testing Services ...
  • IT/EU REGULATORY AFFAIRS - Support and management of Technical documenta...

    Product IT/EU REGULATORY AFFAIRS - Support and management of Technical documenta...

    OP Pharma has been providing innovative services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
    Our expertise covers the lifecycle management of pharmaceutical products, whole or in part, ranging from digitization ...
  • GCP Services

    Product GCP Services

    We offer a range of GCP services, from monitoring to audits. Providing comprehensive GCP compliance services for the pharmaceutical industry is one of our specialties.

    A.   Risk-Based Monitoring: 

    ✔ Risk-Based Monitoring for Bioequivalence/Bioavailability Studies (BE...
  • Clinical Trials and Bioequivalence Studies, Clinical Services, Bioanalysis

    Product Clinical Trials and Bioequivalence Studies, Clinical Services, Bioanalysis


    ACDIMA BioCenter is a comprehensive clinical CRO based in Jordan and founded in 2000. ACDIMA BioCenter is a multinational investment operates as business-driven model with focus on supporting the industry of clinical trials and bioequivalence studies services that help expediting their regulatory a...
  • R&D Services

    Product R&D Services

    Our R&D Services are categorized into 8 streams: • Material Science Services

    • Metal and Organic Scavenging Screening Services

    • Organic Synthesis Services

    • Catalysis Services

    • Process Services

    • Chromatography and Purification Services

    • Method D...
  • Integrated Services

    Product Integrated Services

    Huayi Pharmaceuticals offers an integrated service for product development with our partners Weida Clinical Research and Velocyte Analytical Technology for your bioequivalence needs in China. Through these close strategic partnerships, we are able to offer a one-stop service which allows pharmaceutical dev...
  • Drug efficacy, In vitro and in vivo studies

    Product Drug efficacy, In vitro and in vivo studies

    We offer a full range of studies and bioanalytical services, providing powerful tools and rigorous solutions for preclinical drug development of therapeutic candidates, advance lead compounds towards first-in- human trials, and support for ongoing clinical development
  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite

    Product Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite

    AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting. • Case Intake • Case Processing • Case Submission • Risk Manage...
  • Clinical solutions: Trials

    Product Clinical solutions: Trials

    Conscio's in-house clinical Unit has been operating since 2007, with more than 600 BA/BE/PK studies completed and proprietary of over 270 validated bioanalytical methods. Equipped with a 60-bed on-site clinical unit in Prague and a recently opened 36-bed unit in Ostrava, we provide comprehensive services w...
  • BDD Scintigraphy

    Product BDD Scintigraphy

    Gamma scintigraphy is a powerful and versatile technology used to investigate the in-vivo performance of your drug or product. This non-invasive imaging technique allows us to follow the fate of the dosage form and administering it to a volunteer or patient. Not limited to just oral dosage forms, gamma sci...
  • UNITYai.Lit

    Product UNITYai.Lit

    Elevate your literature management with Unityai.Lit - the advanced software platform and the ultimate solution for efficient and validated ICSR processing and identification of publications for signaling and aggregate reports. Developed by Soterius, Inc., Unityai.Lit is not just a tool; it's a transformati...
  • Analytical Services

    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....
  • Cortellis Clinical Trials Intelligence™

    Product Cortellis Clinical Trials Intelligence™

    Confidently and efficiently plan and design clinical trials by reducing time spent compiling and analyzing protocols, sites, outcomes, endpoints and more. Avoid costly protocol amendments, recruitment delays and trial failure by tracking competitive trials, selecting experienced sites, defining the right e...
  • Clinical Trial Services

    Product Clinical Trial Services

    Our experts will accomplish your clinical objectives by leading the way from recruitment strategies, site selection, and clinical logistics, all the way through the regulatory process. 

    We use our own eClinical suite to be more cost-efficient and keep you connected remotely acros...
  • Cell-based Neutralization Assays

    Product Cell-based Neutralization Assays

    Experienced cell-based neutralizing antibody assay capabilities. Our experts, at our GLP/GCP compliant laboratory, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug toleran...
  • DataCollector - High performance IT Infrastructure for Manufacturing

    Product DataCollector - High performance IT Infrastructure for Manufacturing

    The plus10 DataCollector provides a high-performance data infrastructure for the acquisition and pre-processing of machine data from any source such as sensors, machine or robot controllers. Its simple configuration and implementation transforms machine data into Big Data and creates value through high-fre...
  • Clinical Trial Services

    Product Clinical Trial Services

    Our end-to-end global clinical supply chain services, formerly Fisher Clinical Services, are powered by people with an unwavering dedication to serving clinical research and patients around the world. Whether your investigational medicinal product (IMP) is a traditional small molecule, biologic, or advance...
  • CRO Services

    Product CRO Services

    Clinical Development Program (Phase I to IV) Product Registration 
    Pharmacovigilance
    Regulatory Affairs
    Clinical Monitoring 
    Medical Monitoring
    Project Management 
    Medical Writing 
    Quality Assurance - GCP Audits 
    Logistics Coordination 
     
  • EMVS Connector

    Product EMVS Connector

    Platform for FMD 2D codes generation, CMO integration, 2D codes uploading to EMVS
  • Cortellis Regulatory Intelligence™

    Product Cortellis Regulatory Intelligence™

    Navigate the regulatory landscape and efficiently drive strategic decisions with Cortellis Regulatory Intelligence. Get full and timely coverage of global health authority requirements on healthcare products such as drugs, biologics, medical devices and IVDs, and access exclusive expert reports for both in...
  • R & D Laser

    Product R & D Laser

    A small and powerful manually operated tablet laser drilling and writing machine for products of all shapes and sizes. Accommodates tablets, capsules or soft gels and manages multiple recipes. From laser marking soft gels to laser drilling tablets for controlled release, it delivers consistent, high qualit...
  • Clinical Supply Manufacturing

    Product Clinical Supply Manufacturing

    NCEs • Phase I-III formulation process development and clinical supply manufacturing Generic drugs
    • BE sample manufacturing • Process Optimization
  • Clinical Manufacturing

    Product Clinical Manufacturing

    KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical and clinical supply.

    KBI’s experienced team produces high-quality therapeutics and vaccines thro...
  • Approvals And Registration

    Product Approvals And Registration

    Lomapharm GmbH provides wide range of services which includes approvals and registration. One can benefit from the long experience with a large range of pharmaceuticals and their preparation, including analysis. From analysis to approvals: We are a competent partner for solid, liquid and sterile produc...
  • e-Reg: management of Regulatory Affairs' big data

    Product e-Reg: management of Regulatory Affairs' big data

    OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.

    Do you have lots of products and/or products' data which you cannot organize/archive interna...
  • Cortellis Competitive Intelligence

    Product Cortellis Competitive Intelligence

     Cortellis Competitive Intelligence delivers timely intelligence to survey the entire development landscape and provides comprehensive analysis to forecast trends, threats and opportunities.
  • Clinical Trial Reporting

    Product Clinical Trial Reporting

    The Atlantia Clinical Research team provides a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report, and if the client requests, a full clinical study report.Atlantia maintains no rights to Intellectual Property generated from this study...
  • GCP Services(Good Clinical Practices)

    Product GCP Services(Good Clinical Practices)

    We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

    1) Knowledge: Various regulatory requi...
  • Pre-Clinical Services

    Product Pre-Clinical Services

    Our 3 platforms available are: • Solubility • Solid Dispersion • Nanoparticles
  • Drug Product Development

    Product Drug Product Development

    We support our clients from early-stage research and preclinical phase to and beyond market approval by providing comprehensive development services, including 

    • Developability assessment • Pre-formulation screening • Formulation development • Lyophilization process development • Forced d...
  • Custom Protein Synthesis

    Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...