Technical and Regulatory affairs

Our regulatory experts write the required regulatory documents to be submitted to the European or International Agencies of Veterinary Medicines or Medical Devices.

• – Gap Analysis of existing dossiers and already comercialized products towards new regulatory requirements
• -Writing of part I (expertise), part II (Quality), part III (Safety) and part IV (efficiency) of Market Authorisation (MA) Dossier for National, Decentralized or Mutual Recognition Procedures (MRP)
• -Writing of Export Dossiers (out of EU)
• – Writing of dossier variations
• -Meetings with Regulatory Agencies in Europe for new product development plan validation and strategy definition of existing product support. Answers to the Questions of MA Committees, etc.