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.