SFDA Sector Portal • Muhrat Al Marasim
Pharmaceuticals, BioTech & Biosimilars.
الأدوية والتقنية الحيوية والمثائل الحيوية
SFDA Human Drugs Registration, eCTD Module 1-5 Submissions & GMP Auditing
Regulatory Scope & Architecture
Engineered compliance across the product lifecycle.
Navigate the complex GCC Centralized and SFDA national pharmaceutical authorization pathways. Muhrat Al Marasim supports international pharmaceutical sponsors, biotech innovators, and generic manufacturers in achieving market access across Saudi Arabia.
eCTD Dossier Compilation & Validation
Full compilation and regional lifecycle management of Modules 1 through 5 in XML format compliant with SFDA eCTD validators.
Manufacturing Site GMP Clearance
Preparation, mock audit, and remote or physical SFDA GMP inspection hosting for foreign manufacturing facilities.
Scientific Advice & Pricing Dossiers
Direct liaison with the SFDA Pricing Committee to negotiate sustainable reference pricing frameworks.
Qualified Person for Pharmacovigilance (QPPV)
Local Saudi QPPV appointment, 24/7 adverse drug reaction (ADR) triage, and periodic safety update report (PSUR) submissions.
Guaranteed Statutory Deliverables
SFDA Drug Marketing Authorization (MA)
Approved GCC Product Information Leaflet (PIL) & SmPC
Certificate of Pharmaceutical Product (CPP) Authentication
SFDA Approved Price Certificate
SFDA Filing Readiness Meter
40% ReadySelect the documentation components currently available for your product:
✓
Device / Product Classification & Intended Use Definition✓
Quality Management System (ISO 13485:2016 or GMP)Technical Documentation / Dossier (TFA / eCTD)
Bilingual Labelling & Arabic IFU Artwork
Appointed Independent KSA Authorized Representative
Need Direct Technical Guidance?
Our senior directorate will conduct an initial gap analysis of your dossier before statutory filing.