With our Regulatory Team we provide you 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 in both national, EU and international knowledge in regulatory requirements can support you in:

  • Quality Assurance and Compliance
  • Full Regulatory Review and Support
  • Advisory Board Support and Review
  • Scientific Advice Preparation
  • SME support for non-EU companies
  • Regulatory Support for Clinical Trial Applications
  • Full MAA Management and Preparation
  • CMC (Quality), Non- Clinical & Clinical Data Review and Gap Analysis
  • Publishing and Regulatory Lifecycle Management