Regulatory Support

Clinical Research and Regulatory Writing

Regulatory Affairs

QC and QA of regulatory documents

  • Clinical Research Documents
  • Common Technical Document/Dossiers for
  • Clinical Trial Disclosures
  • Web Synopsis
  • Lay Summaries
  • Product Labelling
  • For submissions in various geographical regions  (IND, NDA, MAA, CTA, etc.)

  • Protocol
  • CRF and ICF
  • Investigator’s Brochure
  • Clinical Study Reports