Clinical & Regulatory

A successful clinical and regulatory strategy should never rule out creativity.

Our clinical and regulatory group works closely with development teams and our clients to uphold the FDA highest safety standards while ensuring an expedient path to approval. Whether it's helping to formulate a global regulatory strategy, preparing and coordinating FDA submissions, or designing and executing clinical studies, our regulatory experts can get involved from day one to mitigate risk without hindering innovation.

We can serve as the Official Correspondent for FDA submissions, and as the US agent and sponsor for companies located outside the US. We can assist with all aspects of regulatory affairs, and can either serve a coordinating role on clinical trials or handle complete studies from trial design to final submission of clinical results.

Regulatory Capabilities:

Regulatory intelligence and market analysis
Global regulatory strategy
Pre-IDE/IND FDA meetings and applications
510(k), PMA, and NDA submissions
CE Mark TF/STED/Dossier
Import/export certification

Clinical Study Capabilities:

Clinical trial design
Subject recruitment
Site qualification
Selection and coordination of IRB and PI
IRB/FDA protocol submissions
Study execution
Data analysis and validation
Document control and data management
Study report and clinical regulatory submission