GLOBAL REGULATORY AFFAIRS
Over 30 years, we have undertaken global submissions and obtained more than 4500 Marketing Authorizations (MA) / Registrations in various countries from the most regulated ones to emerging countries. We are well versed with different class of products and multiple types of regulatory documentation submissions IND, ANDA, CTD, ACTD, DMF, SMF etc. and running various regulatory procedures.
Proactive Regulatory Affairs to support Business Growth
We help strengthen and sharpen regulatory skills that opens faster pathways to support International Business Growth.
Our services include the following:
- Documentation / Dossier Preparation, Review and Advisory for RA Compliance
- Preparation of DMFs (CTD), IND, ANDAs (CTD, ACTD ) for US and other Regulated Markets
- Review of Dossiers for their correctness and completeness
- Product Registration Dossiers for ROW Market
- Prepare query responses on submitted dossier
- Obtaining MA using the most suitable regulatory pathway
- Dossier Audit of Vendor for Completion & Compliance
- Pre-qualification program for WHO Geneva & other International Procurement Agencies