WHAT WE DO
In-Licensing, Marketing Authorisation & UK/EU Commercialisation
At Neuragenix Pharma, we expand our portfolio through strategic in-licensing, MA acquisition, distribution partnerships, and export opportunities—supporting product owners with compliant, end-to-end regulatory and lifecycle ownership across the UK & EU.
We work with CDMOs, CMOs, manufacturers and commercial organisations seeking a dependable, compliance-driven partner to unlock product value—turning regulatory approval into sustainable market success.
In-Licensing, Distribution & Strategic Growth
We identify and secure value products through in-licensing, MA transfers, distribution agreements, and export pathways—supported by disciplined compliance and commercial planning
- Partnering with product owners, manufacturers, CDMOs & CMOs
- Unlocking UK/EU market potential with compliance-first execution
Marketing Authorisation Applications
End-to-end preparation and submission of UK & EU Marketing Authorisations, built with regulatory foresight to withstand assessment and support long-term success.
- National, DCP and MRP procedures
- Generic, hybrid & established product applications
- Pathway selection + full ownership to approval
Regulatory Strategy & Dossier Development
Submission strategies that withstand regulatory challenge, supported by evidence-based dossier building aligned with current UK and EU expectations.
- High-quality CTD compilation
- Gap analysis & remediation
- Scientific justification & positioning
Lifecycle & Compliance Management
Marketing Authorisation is the start. We protect long-term compliance, label integrity, and MA value through proactive post-approval governance.
- Variations, renewals & change management
- SmPC / PIL / labelling maintenance
- Regulatory intelligence monitoring
Product Selection & Portfolio Development
We prioritise medicines with clear pathways, strong market rationale, and reliable supply—building durable, compliant portfolios that support long-term growth.
- Regulatory feasibility & pathway clarity
- Supply chain reliability
- Market access considerations
- Lifecycle potential & sustainability