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