Implementation of a Quality Management System at a pre-clinical pharmaceutical company
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Summary
The project involved creating and implementing a new Quality Management System (QMS) from the ground up for a pre-clinical pharmaceutical company. This was essential for the company to transition toward clinical-stage development and meet regulatory compliance requirements for operating within a GMP environment. The work included developing all necessary Standard Operating Procedures (SOPs), the Quality Manual, and the Quality Policy. The successful implementation led to the assumption of direct responsibility for the company’s Quality Management
Creation of a new QMS tailored to a biotech start-up
Drafting of all key Quality documents (SOPs, Quality Manual, Policy)
Ensuring alignment with EU, US, and ICH regulatory frameworks
Training and preparation for transition to GMP operations
Assumption of Quality Management responsibility
Maintenance of the QMS
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
