Meet us in India (Greater Noida, Delhi NCR) at CPHI on 26-28 Nov 2024 to Explore our Global Services

Regulatory Intelligence
Regulatory Strategy and Business Consulting
End-to-End Regulatory Support for the Companies Looking for Expansion in to the Regulated and Semi-Regulated Markets
Complete Support for Compilation of USDMF/APIMF/WHO-PQP/ANDA/NDA/IND/BLA/MA Modules with no RTR Assurance for ANDA
Artwork and Labeling
Dossier Query Response Submissions
Post Approval Submissions like Prior Approval Supplement, Change Being Effected Supplement and Variation Filing for Global Market
Lifecycle Management of DMF/ANDA/MA
Regulatory Software (eCTD and Structured Product Labeling)
R&D Regulatory Strategy and Systems
Controlled Correspondence with USFDA
Clinical Overview and Non-Clinical Overview
US Agent Services
Audit and Compliance
Regulatory operation excellence services
Dossier Due Diligence

GLOBAL REGULATORY SERVICES