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.