Need an expert in regulatory filings to fda on generics. Questions are around what changes to an anda require a new filing vs. An amendment. Examples are changing dmf source or api supplier, and changing formulation for injectable drug from powder to lyo or vice versa.
BREEJ Technologies Consulting Group offers Consulting Services to the Pharmaceutical Industry. As P...1.2 Hours Later
I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...1.5 Hours Later
Jai |Zintro Expert
I can help with these types of issues with ANDAs. I have developed, filed and obtained approvals on...1 Day Later