Regulatory

We offer extensive industry experience shaping project plans to meet diverse regulatory requirements. We remain current with regional regulatory requirements as they evolve. Our proactive approach and careful counseling ensure that there are no surprises.

Regulatory services:

  • Consulting with Sponsors
  • Preliminary Consultation with Local Authorities
  • Regulatory Package Set Up
  • Regulatory Submission
  • Responses to Regulatory Body Requests for Information
  • Support for and Participation in Meetings with Regulatory Bodies
  • Medical Device Regulation

Identifying potential regulatory challenges. We carefully review each study protocol in order to identify the potential regulatory country-specific challenges that may arise, and we prepare a response.

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