How Navitas Delivers Best-in-Class Bioavailability & Bioequivalence Study Services

The global generics market is on an accelerated growth path, with the U.S. leading the way, projected to surpass USD 508.37 billion by 2034 at a CAGR of 12.00%. This momentum is driven by rising healthcare costs, expiring patents, and increasing regulatory support for generic drug approvals.

However, growth brings complexity. Regulatory scrutiny is intensifying, requiring generics manufacturers to demonstrate bioequivalence (BABE) compliance with precision and efficiency. Success depends on strategic partnerships with globally experienced Contract Research Organizations (CROs) that offer expertise in bioavailability and bioequivalence (BA/BE) studies, regulatory submissions, and clinical trial execution.

Partnering with a Global CRO with 30+ Years of Experience in BABE study services

Navitas Life Sciences has established itself as a trusted global CRO for Generics, backed by over 30 years of regulatory and clinical expertise. With a track record of 1,600+ BA/BE studies, 500+ validated bio-analytical methods, and a team of 180+ generics experts, we offer unparalleled support in bioequivalence testing, regulatory submissions, and end-to-end clinical trial management.

Our extensive experience enables us to provide:

• Regulatory Success at Scale: Over 40+ successful regulatory inspections, including USFDA, WHO, ANSM (France) and AGES (Austria), ensuring seamless approval processes.
• Strategic Partnerships with 50+ Global Generics Companies: Enabling efficient study & faster market entry for generics
• Advanced Generics clinical trials Capabilities: Three world-class bioequivalence facilities supporting complex generic formulations.
• USFDA Inspection Success: Compliance and Quality

New State-of-the-Art BABE Facility for Next-Gen Generics clinical trials

To further support the demanding needs of generic and innovator pharmaceutical companies, Navitas Life Sciences has invested in a state-of-the-art BABE facility.

The bioequivalence facility boasts a dedicated screening area, enabling efficient participant selection and regulatory compliance. With 150+ beds supported by multiple CPUs, our center can handle large-scale clinical trials while ensuring participant safety and data integrity. A walk-in stability chamber guarantees ideal storage conditions for Investigational Products (IP), maintaining regulatory adherence.

To support advanced bioanalytical research, our facility houses a state-of-the-art bioanalytical lab featuring sophisticated, high-end instruments that deliver precise pharmacokinetic analysis. These advanced capabilities ensure speed, accuracy, and compliance with global regulatory standards, making our Manipal facility a preferred partner for global generics companies.

In the high-stakes world of generics, market leadership depends on regulatory expertise, clinical excellence, and operational efficiency. Navitas Life Sciences is a data-driven, technology enabled pharmaceutical CRO that accelerates market entry while ensuring compliance with global regulatory standards.

USFDA Inspection at the new BABE facility

Navitas Life Sciences recently achieved yet another successful USFDA inspection at its Phase 1 & Bioequivalence Centre in Manipal.

The Phase 1 & Bioequivalence Centre in Manipal recently underwent a rigorous five-day audit focused on a bioequivalence study of a differentiated formulation of an antiepileptic drug. Demonstrating uncompromising quality and compliance, the audit resulted in zero 483 findings for the fifth consecutive year. Key areas of review included data integrity, regulatory compliance, live electronic data capture systems, and clinical automation processes. This milestone reinforces our commitment to operational excellence, ensuring that our partners achieve faster regulatory approvals and accelerated market success.

Streamlining Data Management with CRONOS eDC

Navitas Life Sciences leverages CRONOS eDC, a next-generation electronic data capture (eDC) platform designed for seamless and faster data entry, data retrieval, and accurate documentation, significantly reducing errors and improving study turnaround times. By integrating CRONOS eDC system, we empower generics manufacturers with precise, audit ready data that supports successful regulatory submissions and market approvals.

As the generics industry grows more complex, the right strategic partnerships can mean the difference between market leadership and falling behind. With a proven track record, regulatory expertise, and cutting edge infrastructure, Navitas Life Sciences stands as a trusted partner for generics studies worldwide.

Are you looking to enhance productivity and accelerate market entry? Partner with us today and take the lead in the future of generics. Meet our Expert at the DCAT Week to find out more.

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