Regulatory Tools & Medical Writing

Regulatory Tools

We can provide following regulatory documents:

  • Check list of documents in line with prevalent regulatory submission guidelines for Marketing Authorization Application across Globe
  • Guidance documents for PE, Co-validation, BE, Dissolution profile, CTA and MAA for Brazil, WHO and other markets
  • Global Regulatory Information Sheet covering Critical Parameters i.e. Batch Size & Stability data requirements, Timeframe for Approval, Types of submission, Applicable fees and major regulations

Medical Writing

We provide a range of medical and scientific writing services. It covers:

  • Investigational Medicinal Product Dossier (IMPD)
  • Submission modules (CTD Modules 2.4, 2.5, 2.6, 2.7, Module 4 & Module 5)
  • Patient Information Leaflet and SmPC
  • Expert reports