Selection and supervision over a CDMO
Drug Substance manufacturing scale-up and first GMP production
Scope of work:
Chemistry Manufacturing Control Drug Substance development Project management Selection and supervision over a CDMOThe project focused on the scale-up and manufacturing of a lead molecule’s Drug Substance to support initial clinical development.
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.
Managing the development of the drug substance route of synthesis and manufacturing process for an innovative molecule in the preclinical phase
Scope of work:
Chemistry Manufacturing Control Formulation development Project management Selection and supervision over a CDMOThe project involved developing a manufacturing method for a drug substance that is a candidate for an innovative drug product.
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.