Why Neuragenix Pharma
WHY NEURAGENIX PHARMA
Full-Spectrum Regulatory Execution
We provide end-to-end regulatory services as a Marketing Authorisation holder, not as consultants. Every service is delivered with ownership, accountability, and compliance excellence.
Marketing Authorisation Applications
Strategic submission planning and execution across UK and EU regulatory pathways for generic, hybrid, and established products.
- National Procedure applications (UK MHRA)
- Decentralised Procedure (DCP) coordination across multiple EU member states
- Mutual Recognition Procedure (MRP) for existing national authorisations
- Generic applications with comprehensive bioequivalence assessments
- Hybrid applications leveraging published literature and bridging studies
- Well-established use applications for established medicinal products
- Regulatory pathway selection and optimization based on product characteristics
- Complete CTD dossier compilation aligned with ICH M4 guidelines
Lifecycle & Compliance Management
Proactive management of post-approval obligations, variations, and regulatory maintenance throughout the product lifecycle.
- Type IA, IB, and II variation applications for quality, safety, and efficacy changes
- Marketing Authorisation renewals ensuring continued compliance and market presence
- SmPC (Summary of Product Characteristics) updates reflecting current scientific knowledge
- Labelling and packaging artwork review and regulatory approval coordination
- Annual reassessment and periodic safety update report (PSUR) management
- Post-approval commitments tracking and fulfillment
- Regulatory intelligence monitoring for new guidance impacting existing MAs
- Authority correspondence management and query response coordination
Regulatory Strategy & Dossier Development
Scientifically robust, strategically aligned dossiers built on comprehensive gap analysis and regulatory intelligence.
- Gap analysis identifying documentation deficiencies and strategic solutions
- Module 2 (CTD summaries) development with critical evaluation and justification
- Module 3 (Quality) compilation including pharmaceutical development and manufacturing
- Literature-based Module 4 and 5 strategies for non-clinical and clinical sections
- Scientific justification for regulatory positions and alternative approaches
- Reference product selection and comparability assessments
- Regulatory intelligence monitoring for guidance updates and precedent analysis
- Authority pre-submission consultation strategy and engagement planning
In-Licensing & Portfolio Growth
Strategic MA acquisition, regulatory transfer management, and portfolio integration for long-term value creation.
- Marketing Authorisation transfer applications and regulatory coordination
- Due diligence on existing MAs including compliance history and post-approval commitments
- Regulatory gap assessment for acquired products and remediation planning
- Portfolio integration and lifecycle planning post-acquisition
- In-licensing negotiation support with regulatory and compliance perspectives
- Distribution partnership agreements with MA holder oversight
- Export certificate applications enabling market access beyond UK and EU
- Product lifecycle optimization identifying opportunities for line extensions and improvements
Partnership & Distribution Enablement
Collaborative engagement with manufacturers, distributors, and commercial partners to ensure compliant market access.
- CDMO and CMO coordination for manufacturing and quality agreement alignment
- Distributor partnership structuring with clear MA holder oversight
- Qualified Person (QP) coordination and batch release protocols
- Pharmacovigilance agreement setup and safety data exchange procedures
- Import/export authorization support and regulatory certification
- Supply chain continuity planning and regulatory risk mitigation
- Commercial partner training on MA requirements and compliance obligations
- Multi-party coordination ensuring alignment across regulatory, quality, and commercial functions