NDA CMC

The Regulatory Affairs experts and scientific associates at PharmaDirections can assist in the preparation of the CMC section of your NDA or BLA. We offer individual experts or a team who can individually or collectively provide these services:

Author original CMC documents
Author amendments/supplements
Author Annual Reports
Prepare or review documents for submission
Submit documents to Regulatory Agencies
Conduct Pre-Approval Inspection Preparation (Mock PAI)
Analyze stability trends and set expiry period
Write Pharmaceutical and Process Development Reports
Write up the Stability Studies Section
Review specifications and test methods and make recommendations for improvement