REGULATORY AFFAIRS • PRODUCT REGISTRATION • TRAINING
Expert Regulatory Support for
JFDA, SFDA & GCC Markets
Comprehensive regulatory support for pharmaceuticals, medical devices, food supplements, cosmetics and veterinary products — from initial product classification to successful authority approvals.
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
Sector Expertise
Delivering comprehensive regulatory solutions across mul
tiple industries, ensuring full compliance with JFDA, SFDA,
and CCC regulations from product registration to
post-approval support.
PHARMACEUTICALS
• Product registration (JFDA, SFDA & GCC)
• Manufacturer registration & facility
licensing
• Variations, renewals & lifecycle mana
gement
• CAPA management & follow-up
MEDICAL DEVICES
• Establishment Registration.
• Product Classification.
• MDIL & MDMA Submission & follow-up.
FOOD & FOOD SUPPLEMENTS
• Submission via GHAD portal
• Ingredient & formula compliance
(GSO I SFDA)
• Review of nutritional facts, shelf-life
& health claims
COSMETICS & PERSONAL CARE
• SFDA cosmetics notification & listing
• Ingredient verification (banned/restric
ted lists)
• Arabic labeling & artwork compliance
VETERINARY DRUGS
• vNeeS submissions (Vet-SFDA)
• Manufacturer registration & licensing
• Variations, renewals & CAPA follow-up
FEED ADDITIVES
• SFDA notification / listing
• Product classification support
• Arabic labeling & artwork review
Training & Professional Development
Practical regulatory training designed for professionals seeking hands-on experience with JFDA, SFDA & GCC regulatory systems and procedures.
SFDA Medical Device Registration Training
- Overview of Saudi medical device regulations
- Product classification according to SFDA rules
- Practical demonstration of GHAD & MDMA systems
- Preparation of technical documentation
- Handling authority questions and deficiency responses
Pharmaceutical Registration Training (SFDA/JFDA/GCC)
- Understanding CTD, eCTD & vNeeS dossier structures
- Step-by-step submission process on regulatory platforms
- Common regulatory deficiencies and how to avoid them
- Lifecycle management (Variations, Renewals, CAPA)
Cosmetics & Food Supplement Registration Training
- Overview of Saudi medical device regulations
- Product classification according to SFDA rules
- Practical demonstration of GHAD & MDMA systems
- Preparation of technical documentation
- Handling authority questions and deficiency responses
Customized Corporate Training
-Overview of Saudi medical device regulations
- Product classification according to SFDA rules
- Practical demonstration of GHAD & MDMA systems
- Preparation of technical documentation
- Handling authority questions and deficiency responses
Why Choose Me
Deep Knowledge
Deep knowledge of JFDA, SFDA & GCC regulatory frameworks.
Multi-Sector Expertise
Multi-sector expertise (Pharma, Medical Device, Food, Cosmetics & Veterinary).
End-to-End Project Management
End-to-end project management.
Professional Communication
Clear professional communication with authorities & partners.
Practical Training
Practical regulatory training based on real submission experience.