SFDA Regulatory Software | Saudi Arabia eCTD, Track & Trace & MA Tracker
Novaqis RIM provides end-to-end regulatory lifecycle management for pharmaceutical manufacturers and merchant exporters submitting to the Saudi Food and Drug Authority (SFDA). The platform automates Saudi eCTD Module 1 administrative workflows, monitors 5-year Marketing Authorization renewal deadlines with automated 180/90/30-day alerts, and bridges approved bilingual Arabic/English Package Inserts directly with RSD Tatmeen GS1 DataMatrix packaging serialization.
SFDA (Kingdom of Saudi Arabia)
SFDA Compliance Mandate & Novaqis Solution
How Novaqis Regulatory Information Management (RIM) automates statutory compliance, dossier compilation, and packaging serialization for Saudi Food and Drug Authority.
| Compliance Dimension | SFDA Statutory Mandate | Novaqis Automated Solution |
|---|---|---|
| Dossier Submission Format | Mandatory eCTD (electronic Common Technical Document) format incorporating Saudi-specific Module 1 (Application form, pricing, GMP certificate, CPP, and bilingual labeling). | Pre-configured Saudi eCTD Module 1 folder structure linked directly to Novaqis DMS approved documents, ensuring valid DTD XML hierarchy before submission. |
| Registration Renewal Cadence | Marketing Authorizations expire every 5 years. Renewal applications must be formally submitted at least 180 days before license expiration to prevent import bans. | Automated 180, 90, and 30-day renewal countdown notifications with milestone gates (Dossier Prep, QA Review, Submission, SFDA Query, Approval). |
| Serialization & Packaging Traceability | All secondary packaging must bear a GS1 DataMatrix 2D barcode registered on the SFDA RSD Tatmeen national tracking portal. | Native packaging artwork verification module verifying DataMatrix GTIN, expiration format, and serial number placement against approved die-lines. |
| Bilingual Arabic/English Labeling | Cartons and Patient Information Leaflets (PIL) require verified Arabic and English translations with exact therapeutic claims matching the approved SmPC. | Character-level and pixel diffing engine that inspects Arabic right-to-left typography and English text side-by-side against the approved regulatory dossier. |
| Price Certificate & Pricing Submission | SFDA requires price certificates detailing ex-factory, wholesale, and retail prices in 30+ benchmark reference countries in local currency. | Built-in multi-currency commercial pricing module tracking historical reference prices and automatically compiling comparative pricing dossiers. |
Dossier Submission Format
Mandatory eCTD (electronic Common Technical Document) format incorporating Saudi-specific Module 1 (Application form, pricing, GMP certificate, CPP, and bilingual labeling).
Pre-configured Saudi eCTD Module 1 folder structure linked directly to Novaqis DMS approved documents, ensuring valid DTD XML hierarchy before submission.
Registration Renewal Cadence
Marketing Authorizations expire every 5 years. Renewal applications must be formally submitted at least 180 days before license expiration to prevent import bans.
Automated 180, 90, and 30-day renewal countdown notifications with milestone gates (Dossier Prep, QA Review, Submission, SFDA Query, Approval).
Serialization & Packaging Traceability
All secondary packaging must bear a GS1 DataMatrix 2D barcode registered on the SFDA RSD Tatmeen national tracking portal.
Native packaging artwork verification module verifying DataMatrix GTIN, expiration format, and serial number placement against approved die-lines.
Bilingual Arabic/English Labeling
Cartons and Patient Information Leaflets (PIL) require verified Arabic and English translations with exact therapeutic claims matching the approved SmPC.
Character-level and pixel diffing engine that inspects Arabic right-to-left typography and English text side-by-side against the approved regulatory dossier.
Price Certificate & Pricing Submission
SFDA requires price certificates detailing ex-factory, wholesale, and retail prices in 30+ benchmark reference countries in local currency.
Built-in multi-currency commercial pricing module tracking historical reference prices and automatically compiling comparative pricing dossiers.
How Novaqis RIM Accelerates SFDA Submissions & Compliance
Navigating SFDA regulations requires synchronizing regulatory affairs, packaging pre-press, and supply chain release. Novaqis unites these departments on a single validated 21 CFR Part 11 platform.
Pre-Configured Saudi Module 1 Structure
Assemble Module 1 items—Certificate of Pharmaceutical Product (CPP), Letter of Authorization (LoA), GCC pricing certificates, and GMP certificates—with direct document revision locks.
SmPC-to-Artwork Bilingual Bridge
Detect when approved clinical amendments in the Arabic or English SmPC impact carton die-lines or package inserts, automatically initiating a QMS Change Control ticket.
RSD Tatmeen Traceability Verification
Ensure packaging artwork barcodes comply with SFDA GS1 DataMatrix grading (ISO 15415) before cylinders and foils are approved for commercial printing.
SFDA Submission & Compliance Inquiries
Technical guidance on local submissions, dossier structuring, and packaging inspections.
Does Novaqis RIM support Saudi eCTD Module 1 requirements?↓
How does Novaqis prevent unexpected SFDA registration expirations?↓
How does Novaqis handle Arabic text in packaging artwork proofing?↓
Explore Neighboring Export Jurisdictions
GCC & MENA Health Authorities
Novaqis RIM centralizes regulatory lifecycle operations across GCC and MENA health authorities, including UAE MOHAP, Egypt EDA, Jordan JFDA, and Oman MOH. The platform manages multi-country Marketing Authorizations, coordinates Gulf Health Council (GHC) centralized tenders, automates bilingual Arabic/English packaging variations, and tracks regulatory submissions across transitioning eCTD and NeeS formats.
African Health Authorities & Harmonization
Novaqis RIM empowers pharmaceutical manufacturers and merchant exporters expanding across African health authorities, including Tanzania TMDA, Nigeria NAFDAC, South Africa SAHPRA, and Kenya PPB. The platform supports regional harmonization initiatives (EAC and SADC ZaZiBoNa), tracks fast-track regulatory reliance pathways based on WHO Prequalification or stringent regulatory authority (SRA) approvals, and prevents customs holds with automated license renewal forecasting.
ASEAN Health Authorities
Novaqis RIM streamlines pharmaceutical market authorizations across Southeast Asia by natively structuring ASEAN Common Technical Dossiers (ACTD Parts I–IV) for NPRA Malaysia, BPOM Indonesia, FDA Philippines, and TFDA Thailand. The system manages Zone IVb stability testing protocols, tracks localized labeling variations (Bahasa Melayu, Bahasa Indonesia, English, Thai), and provides automated 180/90/30-day renewal warnings for all ASEAN export licenses.
Ready to Automate Your SFDA Submissions?
Eliminate missed 5-year renewal deadlines, avoid packaging customs rejections, and coordinate external CDMOs under complete 21 CFR Part 11 audit trails.