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The Common Technical Document (CTD) and eCTD is a set of specification for application dossier for the registration of medicines in regulated and non-regulated markets.. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.

Regulatory Writing

  • New Product Authorization- IND, NDA, ANDA
  • Post Approval Changes and Product Lifecycle Management
  • Clinical and Non-Clinical Overviews
  • Clinical Expert Statements
  • Bio waiver Expertise
  • eCTD/CTD dossier compilation

Clinical Writing

  • Investigator Brochures
  • Clinical Study Protocols
  • Clinical Study Reports (CSRs)
  • Informed Consent Documents
  • Patient Safety Narratives
  • Clinical Evaluation Reports
  • (CER) for Medical Devices

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