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.
We assure client for complete regulatory assistance upto the product registration and All MOH quieres will handle & solve by us.
More than 85 countries
Writing and reviewing of dossier as per CTD / ASEAN CTD / non-CTD (country specific guideline).
Drug Marster File
Writing and reviewing of DMF in CTD format. All MOH queries will reply by us.
Periodic Safety Update Report
Complete Periodic Safety Update Report (PSUR) document solution for export registration in CIS and other countries
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.
Address MYdossier.in (Dossier Consultancy Division of Zodiac Pharma)
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219) Madanapalle -517 325, Andhra Pradesh India