Project management
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.
Implementation of a Quality Management System at a pre-clinical pharmaceutical company
The project involved creating and implementing a new QMS for a pre-clinical pharmaceutical company.
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.
Modernisation of the formulation development laboratory and the pilot plant
The project aimed to reconstruct and modernise the GMP pilot production area and the formulation development laboratory with a total area of approximately 1,000 to 1,200 m2
Feasibility study for the use of 3D printing in the drug product manufacturing
The project involved examining the possibilities of using 3D printing in pharmaceutical technology.
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.