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