- 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