Bioavailability & Bioequivalence Studies

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

Bioavailability (BA) and Bioequivalence (BE) studies are carried out for developing a new formulation or for marketing a generic drug. In order to market a generic drug, BABE studies are required for approval from health authorities like US FDA. The drug that is being tested is studied against a well- known and commercially available drug, at same concentrations and under conditions that are similar. Companies file their Abbreviated New Drug Application (ANDA) according to 505 (j) or 505b (2) to the US FDA for marketing authorization in USA. Selection of the right clinical research organization is vital for a successful market launch.

With over 90% of the prescriptions in the US market being fulfilled by generics companies, the competition in this space is growing exponentially. This makes it imperative for generics companies to be first-to-market, while adhering to stringent regulatory requirements, ensuring high quality outputs, and maintaining a cost advantage. Navitas Life Sciences is the leading clinical research organization (CRO) with over 100+ marketing authorizations obtained through bioavailability and bioequivalence (BABE) studies. Our capabilities include

BABE Capabilities

Generics

Immediate release Modified release

Complex generics

Patient based bioequivalence studies
Clinical endpoint bioequivalence studies

Special studies

Euglycemic clamp studies
Inhalation studies

Bring Your Generic Product to Market Quickly & Effectively with Our End-to-End Services

01 Study Design

Design & plan your study with our experts to ensure successful outcomes

02 Study Conduct

03 Bioanalysis

04 Data Standardization & Analysis

05 Regulatory Submissions

06 Pharmacovigilance

Our BABE solutions include

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Be first-to-market with your generic product

Gain the competitive edge you need in the generics market with Navitas Life Sciences’ exceptional Bioavailability & Bioequivalence services. Our expert team specializes in delivering efficient, high-quality outcomes that adhere to stringent regulatory standards, propelling your first-to-market strategy.