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We support all your generic drug development needs
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. Ecronacunova is the leading clinical research organization (CRO) with over 100+ marketing authorizations obtained through bioavailability and bioequivalence (BABE) studies. Our capabilities include
Generics Drug Development
Generics
Modified release
Complex generics
Clinical endpoint bioequivalence studies
Special studies
Inhalation studies
Take your biosimilar insulin first to the market
At Ecronacunova, we understand the complexities of biosimilar insulin and have vast experience and technical know-how, along with superlative equipment to get your drug to the market first!
Euglycemic Clamp Studies
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State-of-the-Art Infrastructure Meets Stringent Processes To Conduct Your Inhalation Study
Our best practices include dosing in segregated chambers, videography of dosing, and much more. Our ultra-modern equipment can detect even the lowest lower limit of quantification (LLOQ).