Bioavailability and Bioequivalence Services

• 10+ years of BA/BE study experience

• Global team of experienced professionals

• Regulatory approved, BA/BE centers

• Expertise in pharmaceutical, biopharmaceutical, nutraceutical, and medical device studies

• Strong network of experienced investigators

• Regulatory-compliant services tailored to client needs

• Our ISO and NABL Accredited clinical laboratories

RCS, a Contract Research Organization (CRO) based in India, USA & Europe offers a comprehensive spectrum of Bioavailability/Bioequivalence (BA/BE) services to pharmaceutical, biopharmaceutical, nutraceutical, and medical device companies. With over a decade of experience in conducting BA/BE studies, we are supported by a team of highly qualified global professionals and state-of-the-art BA/BE centers. Our network of experienced investigators ensures the delivery of high-quality, regulatory-compliant studies tailored to meet the unique needs of our clients.

• Replicate Design Studies

• Special Population Studies

• Single and Multidose Studies

• Fed and Fasting Studies

• Cross-Over Studies

• Bioequivalence in First-in-Human (FIH) Studies

• Modified Release Studies

• First-in-Human (FIH) Studies

• Drug-Drug Interaction BA/BE Studies

Advancing Therapeutics with Precision and Expertise

Delivering excellence in Bio-Availability & Bio-Equivalence for global therapeutics

• Study designing

• ICF & protocol development

• Regulatory approvals for project initiation

• Pre-study approvals from IEC/IRB before project initiation

• Subject recruitment & conduct of clinical phase

• Bioanalytical services

• Project management

• Pre & post project regulatory support

• Clinical data management

• Statistical services

• Medical writing services

• Integrated report preparation

• CTD/eCTD submission and CDISC data sets (SDTM and ADaM)

• Data and study material archival

Global BA/BE Services

Why Choose RCS for BA/BE Studies?

• Expertise Across Therapeutic Areas: With experience across a wide range of therapeutic areas, our team understands the unique challenges of each product type and tailors our approach to meet those challenges.

• Global Compliance: We ensure that all studies are conducted in compliance with global regulatory standards, including those of the FDA, EMA, and other major regulatory bodies.

• Comprehensive Reporting: Our detailed reporting process provides you with clear, concise, and accurate results that facilitate regulatory approval and support your product’s market success.

• Patient Safety and Ethical Standards: We prioritize patient safety and adhere to the highest ethical standards in all our clinical trials, ensuring that every study is conducted with the utmost care and integrity.