DMF and ANDA Submissions
Pharmaffiliates prepares appropriate Chemistry, Manufacturing and Control (CMC) regulatory document such as a Drug Master File (DMF) or Active Substance Master File (ASMF) which contains the relevant details of the manufacturing process for an Active Pharmaceutical Ingredient
Our expertise includes:
- Our document enables competent authorities like FDA, EMA to review process information in support of third-party drug product marketing applications.
- We provide a letter of authorization/access that will allow the relevant authorities to review the DMF.
- We submit regulatory documents in the United States, Europe and across the world.
- We rely on decades of experience to power bioequivalence (BE) studies and minimize study failures.
- This competency in the clinical study design is invaluable for ANDAs that require clinical endpoint studies.