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Regulatory Affairs

Regulatory Affairs

Complementary to our clinical study services we offer a wide range of regulatory services for marketing Authorization Application and regulatory file maintenance.

  • Clinical trial applications to Regulatory Authorities and Independent Ethics Committees
  • Notification of Regulatory Authorities
  • Submission of Annual Reports, Development Safety Update Reports (DSURs)
  • Safety reporting on behalf of Sponsors to EudraVigilance
  • Support of Marketing Authorization Applications
  • Maintain Marketing Authorizations, Variations, New API Providers
  • Applications for Patient registries
  • Registration of trials in EudraCT and ClinicalTrials.gov
  • Consulting regarding marketing application strategies and procedures
  • Pre-submission review of product dossier / product information
  • Electronic Submissions (eCTD)
  • Regulatory dossier maintenance and change management