Regulatory

An OPIS team of experts assist clients with regulatory aspects related to clinical studies submissions (Phase I-IV, observational), medical device and nutraceutical products authorization processes.

Qualified staff provide regulatory support in compliance with local and international regulations and guidelines.

Regulatory activities include:

  • Review completeness and accuracy of regulatory documents
  • Prepare submission package
  • Management of electronic submissions according to applicable requirements
  • Support and management of ClinicalTrial.gov and EudraCT
  • Ensure final regulatory authorization are granted
  • Manage

Site selections and Trial Start-Up

Strategically selecting the right sites to conduct clinical trials 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
  • Review, prepare and negotiate the contracts and budgets
  • Ensure final ethics approval are granted
  • Ensure the contracts are fully executed

Contact Us!

Whether you are Sponsor, a Clinical Research Professional or an Investigator contact us to learn more about how we can help.

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