Our experts can audit all type of documents or existing veterinary Safety or Efficacy dossiers against the requirements of current European legislation.

Anistème:

• reviews existing data,
• provides strategic advice and support on preclinical and clinical development,
• writes a complete critical audit with practical recommendations and suggestions,
• proposes solutions:
  • for the development of a new drug and/or therapeutic indication,
  • to update existing dossiers in line with new regulatory requirements,
  • to obtain/renew/extend a marketing authorisation in the EU.