Regulatory affairs

Expertise in quality and regulatory affairs

 

  • Filing DMFs since 1991
  • Founding Member of the GMP Working Group of CEFIC APIC, member since 1994, involved in the development of industry best practice documents (e.g. CEFIC/EFPIA GMP Guide which was one of the baseline documents for ICH Q7, Cleaning Validation Guidance, ICH Q7 How to Do Document, Qualification of Existing Equipment, etc.)
  • Passing successfully FDA inspections since 1991
  • Acting as speaker on GMP Conferences
  • Active member of the Planning Committee for Q7 conferences organized by PDA, presented by the ICH Q7 expert working group members (European Tour in 2002)
  • Dedicated team to support REACH registration (2006/121/EC), the REACH regulation is implemented into our product design process from the beginning.