We support your organization and Regulatory Affairs department if you need extra resources or specialized competencies to support approval of new products or during life cycle management
- A strategic approach to decision on type, contents and timing of regulatory submissions incl. meetings with the authorities and responses to comments from authorities
- Preparation and/or support during approval of regulatory submissions (clinical trial applications, marketing authorisation applications as well as variation applications also including Active Substance Master Files).
Our other services:
- Product Release Support
- Quality Consulting
- Compliance Remediation
- Individual Quality Management Coaching