Our services

Scientific / Medical Writing

Medical Writing is an integral part of drug development and crucial for successful regulatory applications. RPN Scientific and Medical Writers work closely with pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost effective documents to the highest scientific and regulatory standards.

RPN supports clients for the preparation, revision and update of:

  • Pharmaceutical, Clinical and Non-Clinical sections of the Common Technical Document (CTD) for EU and USA Regulatory Authorities (modules 2.3,2.4, 2.5, 2.6, 2.7 and 3)
  • Reformatting of old application dossier to NeeS/e-CTD
  • Product Information (SmPC, PL and labelling)
  • Pharmacovigilance documents such as Pharmacovigilance System Master File (PSMF) and Periodic Safety Update Reports (PSUR)
  • Risk Management Plan (RMP)
  • Investigator’s Brochures
  • Investigational Medicinal Product Dossier (IMPD)
  • Orphan Drug Applications
  • Scientific Advice/Protocol Assistance Applications
  • Paediatric Investigation Plan (PIP)
  • Environmental Risk Assessment (ERA)
  • Response documents
  • Pricing & Reimbursement Reimbursement and Market Access
  • Standard Operating Procedures (SOPs)