Medical Consultancy

“Need for efficacy and safety of the product”

We offer you

  • Medical writing of:
    • Summary of Product Characteristic
    • Patient Information Leaflet
    • Company Core Data Sheet
    • Periodic Safety Update Report (PSUR) / Periodic Benefit Risk  Evaluation Report (PBRER)
    • Risk Management Plan (RMP)
    • Clinical Overview
    • Nonclinical Overview
  • Classifying the products and Legal Requirements

  • Medical and Ethical review of applications for submission to Institutional Review Board/Independent Ethics Committee and follow up communications

  • Medical review of essential trial documents

  • Medical resource person for Pre-Authorisation Phase

  • Writing, reviewing and publication of Clinical Study Report

  • Coding according to Medical Dictionary for Regulatory Activities

  • Pharmacovigilance training for Health care Professional