Consulting

Consulting

Our consulting activity covers:

  • Regulatory affairs input
  1. Development of a regulatory strategy
  2. Interpretation of guidelines
  • Guidance on:
  1. Requirements for manufacturing, IMP characterization and control; import licence, batch release for products manufactured outside of the EU
  2. Requirements for raw materials and process validation
  3. Preclinical tests required for the approval of different clinical phases

 

  • Contact and relation with the EU Authorities: European Medicines Agency (EMA), European Pharmacopoeia and National Agencies.