Our services include:


  • Market research - According to client`s needs may include market positioning, competitors analysis, regulatory requirements report, clinical trials feasibility, etc.
  • Marketing Authorisation Applications (MAAs) - Drugs, Medical Devices, Nutritional Supplments - preparation of local documents, submission, acting as local representative, variations, extensions
  • Clinical Trial Applications (CTAs) - Competent Authority and Ethics Commitees submissions
  • Safety and Pharmacovigilance - Pharmacovigilance data reporting
  • Labelling - Labels preparation according to local guidelines and requirements
  • Regulatory Consulting - Wide range of regulatory issues
  • Strategic Planning- Regulatory strategy, market penetration, product lifecycle
  • Medical Translation - Translation of regulatory documents, medical papers; for more information please visit specialized website
  • Marketing - AlphaPharma is not focused on marketing services but may provide some related services and act as a business intermediary (find local marketing partners for you)