We cover the full product life cycle of post-approval activities in support of licence maintenance, pharmacovigilance and full safety case management. Our post-approval activities include:

  • Integration, where required, of a TMC project manager to manage activities with the client

  • Comprehensive regulatory support

  • Marketing Authorisation variations

  • Management of extraordinary regulatory requirements, e.g., in response to Article 31 procedures

  • Acting as Marketing Authorisation Holder (MAH) for products in transition of ownership, ensuring that a product’s marketing authorisation is maintained whilst partnering activities are underway

  • Scientific/medical service

  • Management of scientific advisory groups

  • Support for the marketing of orphan drugs

  • Manuscripts for publication in literature publications

  • Medical marketing support materials

  • Marketing meeting reports and newsletters

  • Pharmacovigilance support, including the provision of central and local ‘Quality Person Responsible for Pharmacovigilance’ (QPPV)

Get In Touch

Our team is ready and willing to support your needs for post-approval activities.

To discuss your specific project requirements, contact us today.