Preparation of complete Modules 3.2.S. and 3.2.P. for a clinical phase 1 drug (IND filing at the US FDA)
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Summary
The project involved authoring and compiling the complete Chemistry, Manufacturing, and Controls (CMC) information, specifically Module 3 (Quality), for an innovative drug candidate. The goal was to support the company’s first Investigational New Drug (IND) application with the US FDA. The work included synthesizing data from drug substance (DS) and drug product (DP) development programs.
The effort resulted in a comprehensive regulatory dossier that was successfully filed and cleared by the US FDA, enabling the compound to advance to phase 1 clinical trials.
Key points:
CMC strategy definition and execution
Coordination of DS and DP programs
Authoring of the entire Module 3 for the IND application
Ensuring compliance with US FDA regulatory standards
Successful regulatory filing and clearance
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
