OPIS Regulatory Service
A team of experts assist clients with regulatory aspects relating to clinical studies submissions (Phase I-IV, observational), medical devices and nutraceutical products authorization processes.
Qualified staff provide regulatory support in compliance with local and international regulations and guidelines.
Regulatory activities include:
- Reviewing completeness and accuracy of regulatory documents
- Preparing submission package
- Management of electronic submissions according to applicable requirements
- Support and management of ClinicalTrial.gov and EudraCT
- Ensuring that final regulatory authorizations are granted
Site Selection and Trial Start-up
Strategical site selection is essential to ensure the success of a trial.
OPIS has extensive therapeutic specific site knowledge and experience with sites across Europe and dedicated units with local site knowledge manage.Qualified staff provide expertise in submission, follow-up and authorization processes in compliance with local and international regulations and guidelines.
Start-up activities include:
- Country and Site Feasibility
- Site Selection
- Preparation of submission package
- Submissions to IEC/IRB and follow-up
- Contract Review and Budget Negotiation
- Ensuring that final ethics approvals are granted
- Ensuring that contracts are fully executed
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