Bio Analytical Services

We provide a wide range of GCP/GLP bioanalytical services for preclinical and clinical studies with human and/or veterinary drug products up to Phase III. We offer development and validation of bioanalytical methods in different biological matrices; complete bioequivalence studies; pharmacokinetics/toxicok...

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...

We are a Full service CRO with EMA / ISP CHILE / DCGI / CDSCO Compliant  clinical & Analytical Facility for conducting BA/BE studies.
• With 60 bedded  Clinical facility  & Bio- Analytical Facility for BA/BE Studies following strict Regulatory Guidelines Meeting  Internation...

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...

Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes immunogenicity. Kymos have develops new bioanalytical methods for immunogenicity studies of proteins and peptides following ema and fda guidelines on immunogenicity of therapeutic proteins. Depending ...

Take no risk with your analytics when developing new therapeutic monoclonal antibodies. Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical ...

Intertek offers wide range of pharmaceutical services which includes bioequivalence studies. It belongs to bioanalytical services for preclinical and clinical studies category. Contact us for more information.

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...

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...

Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes percutaneous absorption. Kymos shows their experience in studies of percutaneous absorption for topical semisolid drug products using vertical diffusion cells (o franz cells). Both in vitro release te...

Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes bioequivalence studies. Kymos are experts in bioanalysis for bioequivalence studies in collaboration with the sponsor and/or the selected clinical phase center. It has a long list of validated bioanal...

Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes bioanalysis of small molecules. Kymos offer bioanalytical method development and validation of innovative small molecules by mass spectrometry. It has the experience of being the selected partner for ...

With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates. Thanks to our combined experience with small molecule cytotoxics and monoclonal antibodies, we can provide full ana...

Quality Assistance covers all the analytical technologies needed to support your drug development process: CMC (Quality) studies to be perfomed, including Ab characterisation, development and validation of analytical methods, stability studies and batch testing. For Bioanalysis to be performed in Non-clini...

Thanks to 35 years’ experience in analytical sciences and all our laboratories on one site (Mass Spectrometry, Physico-chemistry, Cell Biology, MolecularBiology and Microbiology), Quality Assistance covers all the analytical technologies needed to support your drug development process i...

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 materials, int...

BE studies between products are required for supporting certain changes before approval for a pioneer product in NDA, as a part of ANDA submissions and for certain post approval changes.Important Features: • State-of-the-art analytical facilities having 84 beds • Successfully completed more than 200 BE St...

Oasis Test House caters to the microbiological requirements for its clients serving them with the below analysis. • Preservative Efficacy Analysis • Sterility Test • Sterility Validation • Microbial Limit Test Validation • Microbial count and pathogens • Bioburden testing • Antibiotics assay • Vitam...