Mobirise

MYdossier.in

MYdossier (Division of Zodiac Pharma) is an Indian based Export dossier registration consulting firm.

We offer a wide range of services in the areas of in the areas of Pharma dossier sale, regulatory affairs, handling MOH inquiry, and dossier training for small to mediumVa size pharmaceutical companies to help them to overcome the challenges within the rapidly evolving global pharmaceutical market.



REGULATORY SERVICES

We assure client for complete regulatory assistance upto the product registration  and All MOH quieres will handle & solve by us.

Dossiers

More than 85 countries

Writing and reviewing of dossier as per CTD / ASEAN CTD / non-CTD (country specific guideline).

DMF

Drug Marster File

Writing and reviewing of DMF in CTD format.
All MOH queries will reply by us.

PSUR

Periodic Safety Update Report 

Complete Periodic Safety Update Report (PSUR) document solution for export registration in CIS and other countries

AMV 

Analytical Method Development and Validation

Analytical method development and method validation at our in-house facility. We have Shimadzu LC-2010.

Module 4 & 5

Non Clinical and Clinical Study Reports

Writing and reviewing Module 4 & 5 (Literature based) as per European CTD.

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