Quality Management, Compliance, Licensing & Regulatory support

  • 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.