12 Oct 2020

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 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

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