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
• Manage

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