Biopharmaceutical Classification System (BCS) Biowaiver Assessment & Report; A unique service

Problem Statement Often, competent authorities do not accept BCS biowaiver claim on a test product but insist on carrying out Bioequivalence studies to confirm safety & efficacy comparable to the brand product. The main reason is failure to comply with competent authority guidelines. Alternatively, Biowaiver is often thought of too late in the application stage […]