Strategic Advisory Partner
Our experienced Regulatory Team provide services throughout the entire registration process. From the pre-clinical phase through the complete development of the product to the market and maintenance, we offer support with Regulatory approvals and registrations. We establish planning strategies both for non-clinical and clinical programs and along with medical statistics.
Our experienced team has both national, EU and international knowledge in regulatory requirements and can support you in:
- Full Regulatory Review and Support
- Advisory Board Support and Review
- Scientific Advice Preparation
- Regulatory Support for Clinical Trial Applications
- Full MAA Management and Preparation
- CMC, Non- Clinical & Clinical Data Review and Gap Analysis
