Medical Devices
Regulatory
Regulatory Services – From Strategy to Successful Launch
We offer comprehensive regulatory support tailored to guide your product from early strategic planning through to launch and beyond. Our team brings deep expertise in UK, EU, and global regulatory pathways, ensuring your development program is both efficient and compliant.
End-to-End Regulatory Strategy to Product Launch:
- Strategic regulatory planning aligned with your commercial objectives
- Expert guidance for Scientific Advice Meetings (SAMs) with MHRA and European regulatory bodies
- Communication and liaison with health authorities
- Recommendations on optimal submission routes across the UK and EU
- Support with UK-specific routes including ILAP (Innovative Licensing and Access Pathway) and Unfettered Access Procedure (UAP)
- Navigation of collaborative review initiatives such as Project Orbis and the Access Consortium
- Full preparation and submission of Marketing Authorisation Applications (MAAs)
- Direct interaction with regulatory agencies throughout assessment
- Management of agency questions and negotiations during review
- Pre-approval review of promotional and launch materials
- Product launch coordination across regulatory, marketing, and distribution functions
- Regulatory support for unlicensed medicines ("specials")
- MHRA submissions made on your behalf via direct portal access
Post-Marketing Support & Lifecycle Management:
Our post-approval services ensure ongoing compliance and successful lifecycle management for your products.
- Regulatory gap assessments to identify and resolve compliance issues
- Artwork and packaging mock-up development and review
- Variation applications: strategy, authoring, and submission
- Article 61(3) notifications and updates
- CMC, clinical, and safety-related variations
- Resolution of regulatory deficiencies and Requests for Information (RFIs)
- Line extensions and formulation changes
- Authoring and updates of Quality Overall Summaries (QOS)
- Periodic Safety Update Reports (PSURs) and post-approval commitments
- eCTD publishing, baseline creation, and NTA-to-eCTD conversions
- Generic product applications
- Updating SmPCs, PILs, labelling, and packaging artwork
- Patient Information Leaflet user testing coordination
- Company Core Data Sheet (CCDS) alignment and harmonization
- Translation and linguistic validation of regulatory documents
- Proofreading and quality control of all submissions
- NIMAR (Notification of Intention to Market a Medicine) support