Your Regulatory Partner on Both Sides of the Atlantic
We guide you in your interactions with the FDA, EMA and EU national competent authorities. We prepare:
- regulatory strategies;
- meetings with Health Authorities (scientific advice requests, INTERACT, Type A, Type B, Type C, Type D);
- filings (INDs/IMPDs, CTAs, IBs, and MAAs for human and veterinary medicines),
thanks to our network of experts on both sides of the Atlantic.
Our Regulatory Affairs consultants have experience preparing Regulatory Strategies, Clinical Trial Applications (CTAs), including INDs/IMPDs, and Marketing Authorization Applications (MAAs), New Drug Applications (NDAs) and Biologics License Applications (BLAs) for the EMA and FDA.
Regulatory Strategies
US and EU development and filing pathways.
Health Authority Meetings
Scientific advice, INTERACT, Type A to D meetings.
INDs/IMPDs, CTAs & IBs
Clinical trial filings in the US and EU.
MAAs, NDAs & BLAs
Human and veterinary medicines, for the EMA and FDA.
Talk to a Regulatory Affairs Specialist
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What Happens Next
1. We review your inquiry within 1 business day.
2. A specialist scopes your engagement.
3. You receive a tailored proposal.