IND and IMPD for Clinical Phase
Preparation of complete Modules 3.2.S. and 3.2.P. for a clinical phase 1 drug (IND filing at the US FDA)
Scope of work:
Chemistry Manufacturing Control Drug Substance development IND and IMPD for Clinical Phase Project management Selection and supervision over a CDMOThe project involved authoring and compiling the complete Module 3 for an innovative drug candidate.
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.