Drug Regulatory & Medical Writing

Drug Regulatory

Service offered :-
  • Regulatory strategy development
  • IMPD development / review
  • Label text development / review
  • Procurement of clinical trial liability insurance
  • Providing legal representative services for non-EU customers
  • Collection and review of regulatory documents
  • Compilation of dossiers for CTAs to ECs and CAs
  • Management of submission processes
  • Investigational Product (IP) Release - IPR form
  • Regulatory Management of entire lifecycle of a clinical trial including international and local regulatory requirements compliance
  • Investigational New Drug Application
  • New Drug Approval
  • Clinical Trials strategic planning and submission
  • SEC
  • Regulatory correspondence

Medical Writing

Service offered :-
  • Clinical study Protocols
  • Informed Consent Forms
  • Paediatric Investigation Plans
  • Investigators’ Brochures
  • Clinical Study Reports
  • Annual Safety Reports
  • Journal articles, conference posters and presentations