Regulatory Affairs for Clinical Trials

  • Preparation and submission of clinical trial applications to regulatory authorities (RA) and perform follow up as per RA requirement.
  • To support investigators with the preparation and submission of Institutional Review Board or Ethics Committee documentation
  • Submission of DSUR, SAEs and other reports as per RA requirements
  • Submission of clinical study reports
  • Study transparency/disclosure

PharmXL further provide supports on import and supply and management of clinical trial investigational products.

  • Study drug import and management
  • Permission for Import/export of investigational product and biological samples
  • Management of Investigational product:
  • Local label design
  • Storage & Distribution
  • Return & destruction
  • Facilitation and management of service vendors