OUR SERVICES
Comprehensive Regulatory Support for Your Products
Expert regulatory affairs support for product classification, registration, documentation and authority approvals across JFDA, SFDA & GCC markets.
Supporting pharmaceuticals, medical devices, veterinary products, feed additives, food supplements and cosmetics.
CORE REGULATORY SERVICES
Core Regulatory Services
End-to-end regulatory support from product classification to successful authority approvals.
Product Classification
- Determination of correct category - Submission of official classification requests to JFDA & SFDA
Regulatory Strategy & Consultation
- Regulatory pathway selection - Documentation requirements & timelines - Gap analysis against authority expectations
Dossier Preparation & Submission
- CTD, eCTD & vNeeS formats - Submissions via SFDA & JFDA platforms (SDR, GHAD, e-JDWS) - GCC platforms (Taawon, NashraTech)
Labeling & Packaging Compliance
- Arabic translation & artwork review - Compliance with JFDA, SFDA & GCC labeling regulations
Authority Communication & Deficiency Management
- Responses to authority questions and deficiency letters - Technical justifications & resubmissions - Liaison with foreign manufacturers & local agents