DS4 EU Regulatory Operations

Clinical Investigation Support

From Legal Representative services for non-EU sponsors to submission preparation and ethics committees — we support your EU clinical investigation end to end.

Typical challenges

  • Non-EU sponsors need a Legal Representative (LR)
  • Heavy workload preparing submission documents
  • Coordinating ethics committees and investigation sites is difficult

What we provide

Legal Representative (LR)
LR services for non-EU sponsors
Document review
Preparation and review of submission documents
Ethics committee support
Preparation and handling of ethics committee applications
Authority & site coordination
Support with authorities and investigation sites

How we work

  1. 1Review of your investigation plan
  2. 2LR agreement & document review
  3. 3Ethics committee & authority submissions
  4. 4Ongoing support during the investigation

Related services

Start with a free 30-minute consultation

We help you map your current position: device class, CE status, and EU clinical investigation plans.

Book a free consultation