Medical Devices

GxP Regulatory and Compliance

  • Technical writing and/or review of communications with and submissions to regulatory agencies, including INDs/IMPDs/CTAs, NDAs/BLAs/MAAs, DMFs, and annual reports
  • Internal and external GxP Quality Systems audits according to US and EU regulatory requirements and/or unique client requirements (Learn more about RMC's auditing programs)
  • Remediation Programs (e.g. for actions required from warning letters, partner audits, internal audits, etc.)
  • Mock inspections in preparation for regulatory, certification, or accreditation inspections