Design and implementation of global regulatory strategies to ensure expedited product development and commercialization.
Powered with a team with extensive regulatory agency experience at the European and national level, including former agency reviewers, VCLS advises life sciences companies on effective strategies to develop early phase, innovative technologies, with the prospect of a long-term service to get their products to market. Strategies will provide the optimal regulatory, clinical and health economic pathways available.
Every client case is different and has its own particular needs. At VCLS, we act as the extension of your product development team and offer customized solutions.
Integrated operations bridging over the Atlantic
Our experts in Europe and the US work within a project matrix teams to provide our clients with coherent regulatory advice and strategies that cover the full range of development activities from preclinical development right the way through to marketing authorization and product lifecycle management. The outputs provide a pathway suitable to navigate the FDA and EU agencies’ requirements.
Global Regulatory Strategy & Roadmaps
- Gap analysis
- Integrated product development planning and execution
- Product positioning
- Regulatory pathway
- Due diligence
- Market Access Considerations
Global Regulatory Preparation & Submissions
- MAA (Centralized procedure, mutual recognition procedure, decentralized procedure) / NDA / BLA / IND
- Clinical trial applications (INDs, CTAs, CTNs)
- CE-marking technical files
- Integration of HTA insights
Regulatory Agency Interaction
- EMA, National Scientific Advice
- Pre-IND, EOP2 meetings, pre-NDA meetings
- EMA SME meetings
- ITF meetings
- EMA/HTA parallel consultation
Regulatory Lifecycle Management
- Strategy and implementation
- Post-approval lifecycle management including variations, amendments, renewals, supplements and annual reports
- SME status
- US agent
- ODD sponsor