Regulatory Affairs

In a world of constantly changing regulatory demands, and with the increasing complexity of clinical trials, CirQuest Labs offers key services for compliance with regulatory authorities.

CirQuest’s regulatory capabilities include:

  • Managing IRB/EC submissions
  • Managing submission of study documents, protocol amendments, revised consent forms, updated investigator brochures, patient materials, etc.
  • Maintaining regulatory documents
  • Reporting of monitoring/site validation visits
  • Assisting with Corrective/Preventive Action plans that may be associated with responding to FDA audits
  • Providing preparation and planning for meeting with government and regulatory agencies