End-to-End Regulatory Strategy for Global Market Access
Maven provides comprehensive regulatory strategy services to help clients navigate complex compliance landscapes and achieve smooth product approvals across the US, EU, and ROW markets. Our team ensures your product meets all regulatory requirements, enabling faster market entry and sustained compliance.
Key Regulatory Submissions
- NDA & ANDA: New Drug Application and Abbreviated New Drug Application submissions to the FDA, including 505(j) and 505(b)(2)
- IND & IMPD: Investigational New Drug and Investigational Medicinal Product Dossier submissions for clinical studies
- MAA: Marketing Authorization Applications for hybrid or generic products in the EU and UK
European Authorization Pathways
- Centralised Procedure (CP): For orphan drugs, biotech products, and treatments for AIDS, cancer, diabetes, etc.
- Decentralised Procedure (DCP): Simultaneous authorization in multiple EU countries
- Mutual Recognition Procedure (MRP): Based on existing national authorizations
- National Procedure (NP): Country-specific submissions
Regulatory Intelligence & Market Reports
- Geography-specific regulatory pathways
- Product categorization and classification
- Labeling and packaging requirements
- Clinical study and GxP compliance
- Import regulations and legal agent requirements
Maven supports a wide range of products including pharmaceuticals, biologics, medical devices, cosmetics, nutraceuticals, and consumer goods. Our reports and strategies are tailored to each client’s industry and target geography.
