Accelerating Biosimilars and Generics with Advanced CRO Services

Be First-to-Market with Our Bioavailability & Bioequivalence (BABE) CRO Services

Bioavailability (BA) and Bioequivalence (BE) studies are critical components in developing or marketing a generic drug. To secure approval from global health authorities such as the US FDA, pharmaceutical companies must conduct a bioequivalence study comparing their test product with a well-known reference drug under similar conditions. Understanding what is a bioavailability study and selecting the right clinical research organization in the US can determine the success of your market entry strategy.

With over 90% of prescriptions in the US market being fulfilled by generics, competition has never been more intense. To stay ahead, companies must accelerate development while ensuring compliance and quality. Navitas Life Sciences, a leading CRO (Clinical Research Organization), has successfully conducted 1600+ BABE studies, supporting 100+ marketing authorizations through rigorous bioavailability and bioequivalence study execution. Our CRO services are designed to help you bring your complex generics to market quickly and effectively.

Comprehensive Capabilities in Generics and BABE Studies

Our infrastructure and expertise enable seamless end-to-end execution—from study design to regulatory submission.

Key strengths include:

• 3 Clinical Pharmacology Units with 230 beds and advanced bioanalytical labs equipped with 16 mass spectrometers.
• Inhalation chambers and specialized setups for euglycemic clamp and patient-based bioequivalence studies.
• Expertise across immediate release, modified release and complex generics formulations.
• Proven excellence in clinical trials for generic drugs, supported by robust data analytics, pharmacovigilance and regulatory expertise.

Our CRO clinical trials team comprises 180+ experts, including physicians and PhDs, ensuring the highest standards of quality, safety, and compliance.

Experience World-Class Infrastructure for Your Inhalation Studies

Managing inhalation studies involves unique scientific and operational challenges — from aerosol delivery and patient training to precise quantification of drug deposition. At Navitas Life Sciences, every aspect is managed through state-of-the-art facilities and rigorous SOPs that ensure accurate, reproducible outcomes.

Our bioanalytical teams have developed over 500 validated Bioanalytical methods for drug quantification. When new methods are required, our experts can develop and validate them within four weeks, ensuring project timelines stay on track.

Euglycemic Clamp Studies: Precision in Insulin Sensitivity Assessment

Navitas Life Sciences specializes in hyperinsulinemic euglycemic clamp studies, recognized globally as the gold standard for assessing insulin sensitivity in humans. This advanced technique maintains steady blood glucose levels using a variable glucose infusion rate (GIR) to measure the glucose-lowering effect of biosimilar insulin compounds. Our deep experience supports biosimilar insulin programs across all phases, offering a seamless transition from biologics vs biosimilars development to regulatory submission.

With access to state-of-the-art glucose analyzers, ECLIA analyzers, and triple quad mass spectrometers, we ensure unmatched accuracy and reproducibility. Validated ligand-binding and chromatographic assays allow precise estimation of insulin, its analogs, and metabolites. Our infrastructure and domain expertise make us one of the few clinical research organizations in the US capable of delivering end-to-end support for euglycemic insulin studies.

Your Trusted Partner for Euglycemic Clamp Studies

Navitas Life Sciences brings a strategic advantage to biosimilar insulin development by combining scientific precision with operational agility. Our dedicated teams manage every phase of your study—ensuring optimal design, risk mitigation, and robust data analysis. With deep insight into insulin analog behavior and large-molecule dynamics, we streamline complex development programs and accelerate time-to-market.

Highlights of Our Euglycemic Clamp Study Support:

• Custom-designed studies aligned with compound-specific needs
• Dedicated teams with deep expertise in insulin clamp methodology
• Intelligent monitoring solutions and effective project design
• End-to-end regulatory and analytical support
• Proven excellence in advancing biosimilar insulin programs to successful approval
• Ensuring Biosimilar Success with Comprehensive CRO Support

Ensuring Biosimilar Success with Comprehensive CRO Support

The evolution of biologics vs biosimilars has redefined therapeutic innovation. As the demand for cost-effective biologic alternatives rises, it is essential to understand the nuances of biosimilars vs generics and navigate the complex regulatory landscape. Navitas Life Sciences offers comprehensive solutions for biosimilars development, combining scientific depth, operational excellence and regulatory insight.

Our expertise in biosimilar clinical trials ensures thorough molecular characterization, precise study design, and compliant execution. As a trusted CRO partner, we deliver integrated CRO services that cover every stage, from preclinical development to post-marketing surveillance. By leveraging our experience in both biologics vs biosimilars and biosimilars vs generics, we help clients reduce risk, optimize cost and achieve faster market access.

Innovative Solutions for Biologics and Complex Generics

Navitas Life Sciences ensures innovation at every stage of our biosimilar and complex generics programs. Our teams apply deep scientific and operational expertise to ensure high-quality outcomes in CRO clinical trials. As one of the most trusted clinical research organizations in the US, we deliver efficiency and accuracy through advanced bioanalytical methods and a data-driven approach.

Whether you are developing a biosimilar or planning your next clinical trial for generic drugs, our CRO companies framework provides the scalability, precision, and compliance needed for global success.

Learn more about our services and solutions by reaching out to us at This email address is being protected from spambots. You need JavaScript enabled to view it..