Developed customized Quality Systems for a clinical-stage European firm that met Regulatory Agency requirements while minimizing resources required
Performed gap analysis and prepared corrective action plan
Advocated and persuaded senior management to promptly adopt the plan
For the Legal department, advised on & prepared template for contractual Quality Agreements with manufacturing and testing partners
Initiated development of an ICH-compliant, risk-based Pharmaceutical Quality System (PQS)
. Identified, prioritized and authored the first set of SOPs
. Worked with Pharmaceutical Development staff to develop Quality Policies and to complete the PQS
For the Clinical group, reviewed & revised draft SOPs and performed training
OUTCOME: The firm now has working Quality Systems which meet Regulatory Agency (EMA) requirements, are tailored to the firm’s activities, are not overly burdensome, and are easily adaptable as the firm’s activities evolve.
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Contact us at +1 484 758-0654 or by email