• Comprehensive regulatory support
  • Management of extraordinary regulatory requirements, e.g. in response to Article 31 (formerly Article 12) procedures. Clients have found it useful to have these activities managed by a TMC project manager integrated into the client's team.
  • Acting as Marketing Authorisation Holder (MAH) for products in transition of ownership. Ensuring that a product's marketing authorisation is maintained while partnering activities are under way
  • Marketing authorisation variations
  • Pharmacovigilance, including provision of central and local QPPVs
  • Scientific / Medical Service
  • Support for marketing of orphan drugs
  • Medical marketing support materials
  • Manuscripts for publication in the literature
  • Management of scientific advisory groups
  • Marketing meeting reports and newsletters