Analytical Methods (Biopharmaceutical Services)

Container closure systems, drug delivery devices, and packaging materials can introduce potentially harmful chemical entities into drug products — making Extractables and Leachables (E&L) testing a critical component of pharmaceutical safety and regulatory compliance. ResolveMass Laboratories offers ad...

We offer the development and validation of test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices. Our method development and method validation are in accordance wit...

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

Alcami offers fully-integrated analytical method development, method validation and testing solutions for raw materials, API/BDS and Drug Product.Built on a foundation of comprehensive analytical services for pharmaceuticals including biologics, our advanced laboratories and experienced scientist...

Coriolis Pharma offers release testing services to ensure that drug products meet their intended target product profile, safety, efficacy, and regulatory standards. Our analytical offerings include both compendial and custom methods for purity, identity, potency, particle and aggregate analysis, polysorbat...

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...

From a drug product’s first raw materials to its release-ready batches, our experts rigorously evaluate and verify a product’s quality at key steps throughout the manufacturing process. Analytical services include material testing to verify product quality from the early stages of development, cGMP-com...

PTI’s non-destructive inspection technologies verify container closure system integrity. Deterministic quantitative leak test methods for vials, ampoules, syringes, cartridges and auto-injectors. Applications include stability studies, clinical trials, quality assurance testing and statistical process cont...

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

ICON’s Accelerated Pharmaceutical Solutions provide a seamless, end-to-end approach to formulation development and optimisation for small molecules and biologics. Our comprehensive services cover everything from formulation screening and optimisation to analytical method development, validation, and custom...

ARL Bio Pharma has extensive experience with chemical, manufacturing and controls testing for original and abbreviated new drug applications. This testing includes: identification tests, quantitative tests for impurities content, limit tests for the control of impurities, performance tests such as dissolut...

ResolveMass Laboratories offers comprehensive Peptide Drug Development Services designed to support pharmaceutical companies navigating the complex regulatory and analytical landscape of peptide-based therapeutics. Our expertise spans the full lifecycle of peptide injectable development, including long-act...

Observing visible and subvisible particles can stagnate the drug development or the batch release process. Coriolis Pharma has the experience and the capacity to determine the identity and possible origin of particulate matter in your biopharmaceutical drug products—crucial for troubleshooting and root-cau...

At Coriolis Pharma, combination product development integrates formulation science with device compatibility—such as vials, prefilled syringes, cartridges, and other primary packaging—to deliver seamless drug-device solutions. From early-phase preclinical studies through to late-phase clinical and commerci...

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...

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)....

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 production. ...

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 ...

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 ...

ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.

USP / NF (United States Pharmacopeia) testingEP (European Pharmacopeia) testing
JP (Japanese Pharmacopeia) testing

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