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