Quality Management, Compliance, Licensing & Regulatory support - Medical Cannabis extraction technology

cGMP compliance, regulatory issues, validation strategy and quality systems, acc. to EU cGMP / FDA 21 CFR, practices, HACCP/GFSI, GACP.
Gap Analyses and Risk Assessments for systems, processes & products.
Pre-audit Gap assessment. Support Inspections, CA audits, third-party audits. Preparation for Manufacturing Authorization submission and finalization.
Creation of an integrated Quality Management System (QMS) framework.
Regulatory requirements and strategy for product registration.
Drug Master File (DMF) drafting for clinical, pharmacological and toxicological data compilation (publicly available) and/or acquisition thereof.
Coordination and point of contact with Contract Research Organizations (CRO) on the various contracted activities.
Preparation of Marketing Authorization (MA) documentation submission, extension and variations according to the respective regulation.