Regulatory Strategy

Our strategic regulatory consulting experts serve clients around the globe—from biotech start-ups to global pharma and medical device—as well as the research. Our comprehensive regulatory consulting services include:

1. Global requirements and regulatory strategy
2. Global regulatory intelligence
3. Due diligence 
4. Development plans and briefing documents
5. Submissions and interactions with regulatory agencies, including:
   • 1. Scientific advice and agency meetings
     2. Orphan drug and PIP activities
     3. EU and UK Orphan drug designation
     4. eCTD services
6. Quality and compliance support
7. Risk management and mitigation strategy
8. Regulatory maintenance of approved products
9. Environmental regulatory services
10. CMC, non-clinical consultancy and clinical development consultancy