Pharmaffiliates specializes in preparing detailed Chemistry, Manufacturing, and Control (CMC) documents, including Drug Master Files (DMFs) and Active Substance Master Files (ASMFs), to support API manufacturing processes.

Our expertise includes:

• Our documentation allows regulatory authorities such as the FDA and EMA to assess manufacturing processes in support of third-party drug product applications.
• We issue letters of authorization or access to enable regulatory agencies to review the submitted DMF.
• We handle regulatory submissions across the United States, Europe, and other major international markets.
• With decades of experience, we support bioequivalence (BE) studies by ensuring accuracy and reducing the risk of study failure.
• Our expertise in clinical study design is instrumental in the success of ANDAs requiring clinical endpoint evaluations.