About Us
Ecron Acunova is a clinical research organization (CRO) that specializes in bioavailability and bioequivalence (BABE) studies. BABE studies are required for approval from health authorities like US FDA for marketing a generic drug. With over 100+ marketing authorizations obtained through BABE studies, Ecron Acunova is the leading CRO in this space.
Our capabilities include generics such as immediate release, modified release, complex generics, patient-based bioequivalence studies, clinical endpoint bioequivalence studies, special studies such as euglycemic clamp studies and inhalation studies.
At Ecron Acunova, we understand that 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.
We offer end-to-end services to bring your generic product to market quickly and effectively. We support your Abbreviated New Drug Application (ANDA) according to 505 (j) or 505b (2) to the US FDA for marketing authorization in USA and across the globe. Our services include study design, study conduct, bioanalysis, data standardization and analysis, dossier preparation, and regulatory support.
Conducted
Developed
Doctors & PhDs)
Authorizations
Leadership
Generics & Managing Director
BA/BE Services
BA/BE Services