Welcome to Medi Tree India

Email : business@meditreeindia.com
  Contact : 1800 - 274 - 4732

Dossier Services

At Meditree we have expertise to create dossiers for registration of Pharmaceutical Formulations, Medical Devices and other regulated products for Regulated Markets, Lesser Regulated Markets and Emerging Markets.

Meditree having a backing of product development labs have a bank of dossiers for many markets and also undertakes preparation of a technical dossier on specific request.

HOW WE CAN ASSIST :

DOSSIER PREPARATION

  • Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK,
  • Preclinical and clinical Overviews / Summary writing based on literature search / Published studies / articles from journals .
  • Dossiers for ASEAN and ROW countries in ACTD/ as per country specific format.
  • Evaluation of existing dossier for its adequacy in respect to a particular country
  • Product information updates (SmPC, PIL and Labeling).
  • Preparation of Drug Master File and Certificate of suitability (open and closed part)

DOSSIER REVIEW AND MAINTENANCE

  • Review by counterparts in Europe of dossiers prepared for registration in EU/UK.
  • Dossier review by special teams for other markets
  • Provide EU-QP services for Pre-clinical and Clinical modules.
  • Handling of all types of variations (Type Ia, Ib and II), annual reports, renewals of MAAs and support in query responses.