TMC Pharma Services span the full product life-cycle

Post-approval activities

• 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 not lost while partnering activities are under way

• Marketing authorisation variations

• Pharmacovigilance

• 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