Legal Representative
EU representation for performance studies
For sponsors of performance studies based outside the European Union, appointing a legal representative within the Union is a regulatory requirement. QbD Group provides expert EU representation.
What is a legal representative?
A Legal Representative is an individual or legal entity established within the European Union that is designated to act on behalf of a non-EU sponsor for regulatory matters related to performance studies. This role is crucial for ensuring that performance studies meet the regulatory requirements set by the EU, including submission to National Competent Authorities and Ethics Committees.
For sponsors of performance studies based outside the European Union, appointing a legal representative within the Union is a regulatory requirement.
How we support you
QbD Group can provide your study with the expertise needed to guide you through the regulatory landscape and ensure full compliance with EU requirements.
Regulatory representation
Act as your legal representative for performance studies in the EU.
Authority submissions
Handle submissions to National Competent Authorities and Ethics Committees.
Compliance assurance
Ensure full compliance with EU regulatory requirements for performance studies.
Communication hub
Serve as the point of contact between sponsors and EU regulatory authorities.
Why QbD Group
Your trusted partner
Our legal representative services ensure seamless EU market access for your performance studies.
Established EU-based entity with deep regulatory expertise.
Experience across multiple therapeutic areas and device types.
Proven track record in managing EU regulatory interactions.
Seamless coordination between sponsors and competent authorities.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.