Helping clients to navigate complex global regulatory requirements and emerging issues
60+Projects in over 60 countries
We work with you to take a rigorous, integrated, strategic approach to global regulatory affairs. Our global regulatory consulting and advisory team has worked with hundreds of clients in more than 60 countries.
For any project, at any phase, anywhere in the world
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, investment, and legal firms that serve them. Our comprehensive regulatory consulting services include:
- Global requirements and regulatory strategy including:
- US regulatory support (PDF)
- EU regulatory support (PDF)
- Canadian regulatory support (PDF)
- Latin American regulatory support (PDF)
- Global regulatory intelligence
- Due diligence
- Development plans and briefing documents
- Submissions and interactions with regulatory agencies, including:
- Scientific advice and agency meetings
- Orphan drug and PIP activities
- eCTD services
- Quality and compliance support (PDF)
- Risk management and mitigation strategy
- Regulatory maintenance of approved products (PDF)
- Environmental regulatory services
- CMC, non-clinical consultancy and clinical development consultancy
Having the right strategy is crucial at all stages of the product lifecycle. Whether you’re preparing for your first pre-IND/CTA meeting or approaching patent expiration, we will help you consider all the options so you can take the most strategic stance.
Doing a submission right the first time can make the difference between being first to market or just another me-too. Whether it’s an eCTD to the FDA, an orphan drug application in Europe, or a medical device in Canada, our experts will help you get to market quickly and smoothly.