Legal Representative
Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative.
Qarad offers this service to act as the performance study sponsor’s legal representative in the EU.
We help you ensure the performance study aligns with the EU’s stringent regulatory standards, minimising the risk of non-compliance.
We facilitate smooth interactions with Competent Authorities through our extensive experience dealing with National Competent Authorities.
We support and guide clients through your complex and ever evolving regulatory landscape of performance study applications or notifications so they can focus on the science.
Qarad acts as your legal representative!
We possess in-depth regulatory knowledge so you can focus on the science.
Part of QbD Group
This service is supported by Qarad
How can we support you?
Strategic Advice
- Assess regulatory requirements for the study (authorization or notification).
- Help define the submission strategy.
Submissions
- Compiling Annex XIV compliant submission packages.
- Ethics Committee submission.
- Competent Authority submission.
- Submission planning and strategy.
- Study amendments/modifications & study termination.
We help our clients ensure the performance study/clinical investigation complies with the EU’s stringent regulatory standards, minimizing the risk of non-compliance.
We facilitate smooth interactions with Competent Authorities and Ethics Committees.
We support and guide clients through their study application or notification projects.
Why QbD Group?
Where QbD Clinical acts as the sponsor’s legal representative, the sponsor is not required to establish an office in the EEA during the clinical phase.
QbD Clinical will assist the sponsor in understanding the regulations, staying abreast of these requirements, addressing any questions from the European Authorities, and consulting with the sponsor in full transparency to provide a tailored solution.
Contact us
Contact us for more information or to request a free, no-obligation proposal.
