Holding a marketing authorisation or managing unlicensed supply 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 both licensed and unlicensed 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 biotechs to support both licensed and unlicensed medicines
- Integrated regulatory, pharmacovigilance and medical information services
Our expertise includes
eCTD and eSubmissions
- Preparation of CTD and eCTD-compliant submissions
- Life cycle management for global submissions
- Authority-specific formatting and validation
e-Publishing
- Compilation and formatting of submission-ready documents
- Technical validation and publishing to authority specifications
- Global submission management and tracking
Regulatory operations and publishing
- Submission planning and document management
- Health authority correspondence and submission tracking
- Full regulatory back-office capability
Regulatory procedures
- Management of national, decentralised and centralised procedures
- Support with marketing authorisation transfers and variations
- Coordination of responses to health authority queries
Labelling and artwork support
- Review and localisation of product information
- Updates to SmPCs, PILs and packaging
- Alignment with regulatory and safety requirements
Looking for support across your product portfolio?
We can hold your licences, maintain compliance, and manage submissions and variations across markets.