We assure client for complete regulatory assistance upto the product registration and All MOH quieres will handle & solve by us.
Writing and reviewing of dossier as per CTD / ASEAN CTD / non-CTD (country specific guideline).
Writing and reviewing of DMF in CTD format.All MOH queries will reply by us.
Complete Periodic Safety Update Report (PSUR) document solution for export registration in CIS and other countries
Analytical method development and method validation at our in-house facility. We have Shimadzu LC-2010.
Writing and reviewing Module 4 & 5 (Literature based) as per European CTD.
AddressMYdossier.in(Dossier Consultancy Division ofZodiac Pharma)Plot No. 63, 76 & 77,Industrial Park (APIIC) Valasapalli,(On Sate Highway No 219)Madanapalle -517 325,Andhra Pradesh India
Contacts ( For dossier / DMF/BE /AMV services)
YES ! We Can