Holding a Marketing Authorisation is complex. We make it easier.
Clinigen provides global support across the full regulatory lifecycle – whether you need us to hold the licence, maintain compliance, or manage submissions and variations. With deep expertise in the transition to launch and licensed medicines, we act as your trusted partner in new market entry, lifecycle maintenance and regulatory operations.
Why choose Clinigen
- Holder of 400+ product licences across Europe, UK, US, JAPAC and Africa
- Trusted by biopharma companies to support licensed medicines
- Breadth of services to enable support pre- and post-commercial launch
- Integrated regulatory, pharmacovigilance and medical information services
Our expertise includes
Strategy and Launch Transition
- Holistic access strategy that includes transition from unlicensed supply to commercial launch in key markets.
- Product acquisition and divestment regulatory due diligence and management of licence transfers.
- Geographic expansion strategy to extend market reach, including holding licences pre- and post-commercial launch.
- Licence optimisation, including new strengths, indications and line extensions.
Regulatory Procedures and Maintenance
- Full regulatory back-office capability, including licence holding
- Management of initial marketing authorisation applications
- Marketing authorisation maintenance submissions, including variations, supplements and periodic reports
- Coordination and preparation of responses to health authority queries
- Pro-active compliance management via product leads
eCTD and eSubmissions
- Compilation and formatting of submission-ready documents
- Authority-specific formatting and validation
- Preparation and delivery of CTD and eCTD-compliant submissions
- Life-cycle management for global submissions
Labelling and artwork support
- Preparation of product information to meet local requirements
- Updates to product information and artwork
- Alignment with regulatory requirements whilst meeting commercial aims
Looking for support across your product portfolio?
We can hold your licences, maintain compliance, and manage submissions and variations across markets.