Techniques
Regulatory Services
Our Regulatory Team is dedicated to assist our clients with the requirements for submission of bioavailability and bioequivalence data. We offer end-to-end regulatory services for the establishment of bioequivalence.
The Office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhavan, New Delhi, reviews applications and grants approval to carry out bioequivalence studies with various pharmaceutical dosage formulations on healthy volunteers.
On behalf of sponsors, including both manufacturers & importers, we submit an application to DCGI for bioequivalence study and license for product (RLD) import and testing.
In addition, our experts help in handling any queries from the regulatory authority before and after the completion of bioequivalence studies.
