AI-powered CTD/eCTD dossier review against SFDA requirements. Identify gaps before submission, reduce RFI cycles, and accelerate your drug registration in Saudi Arabia.
SFDA has the most stringent pharmaceutical regulations in the Middle East. ByteBeam automates compliance verification.
Saudi Food and Drug Authority - The primary regulatory body for drug registration and market authorization in Saudi Arabia
International Council for Harmonisation Common Technical Document format required for all SFDA submissions
GCC Standardization Organization requirements for pharmaceutical products across Gulf countries
Traditional gap analysis is expensive, slow, and still misses critical deficiencies.
Typical SFDA registration timeline—delays often caused by incomplete dossiers and multiple RFI cycles
Average CTD dossier contains hundreds of pages across 5 modules requiring meticulous review
Cost of dossier rework, resubmission fees, and delayed market entry for each major deficiency
Comprehensive AI-powered dossier review that catches what manual reviews miss.
AI reviews all five CTD modules against SFDA-specific requirements, identifying gaps in administrative, quality, nonclinical, and clinical documentation.
Identify missing documents, incomplete data, formatting errors, and content inconsistencies before SFDA reviewers find them.
Receive a detailed gap analysis report with prioritized findings and actionable remediation steps for each identified issue.
Verify eCTD structure, file formats, naming conventions, and technical specifications match SFDA validation criteria.
Detect inconsistencies between Module 2 summaries and supporting data in Modules 3, 4, and 5—a common cause of RFIs.
Review multiple product dossiers simultaneously. Scale your regulatory operations without adding headcount.
What used to take weeks of manual review now takes days.
Upload your CTD/eCTD dossier files—we handle all formats including PDFs, XML, and compiled eCTD sequences.
Our AI reviews every module against current SFDA guidelines, checking for completeness, consistency, and compliance gaps.
Get a comprehensive gap analysis report with prioritized findings, specific references to SFDA requirements, and remediation recommendations.
ByteBeam analyzes all five CTD modules against SFDA-specific requirements.
AI-powered analysis completes in days what manual review takes weeks to accomplish.
Process multiple dossiers simultaneously without expanding your regulatory team.
Catch deficiencies before submission, cutting SFDA RFI cycles by 50% or more.
Every dossier receives the same thorough analysis—no variability, no oversights.
Common questions about SFDA pharmaceutical registration and gap analysis
A dossier gap analysis is a systematic review of your drug registration documentation (CTD/eCTD format) against regulatory authority requirements—in this case, SFDA. It identifies missing documents, incomplete data, formatting issues, and compliance gaps before you submit, preventing costly rejections and reducing approval timelines.
SFDA requires a complete eCTD dossier with all five modules: Module 1 (Administrative—including the National Application Form, SPC, PIL, QPPV details), Module 2 (Summaries), Module 3 (Quality/CMC data), Module 4 (Nonclinical studies), and Module 5 (Clinical studies). Additional requirements include a Certificate of Pharmaceutical Product (CPP), GMP certificates, stability studies, and for generics, bioequivalence data.
Standard SFDA drug registration takes 6-12 months for complete, compliant submissions. However, dossiers with deficiencies can take 18-24 months or longer due to multiple Request for Information (RFI) cycles. A thorough gap analysis before submission can significantly reduce this timeline by ensuring first-time compliance.
The most common deficiencies include: incomplete or outdated stability data, inconsistencies between Module 2 summaries and supporting modules, missing or incorrect QPPV information, incomplete API (3.2.S) documentation, inadequate bioequivalence studies for generics, non-compliant labeling (PIL/SPC), and eCTD technical validation errors.
Yes. ByteBeam's gap analysis covers both new drug applications (NDAs) requiring all five CTD modules and generic drug applications which typically focus on bioequivalence and quality modules. The AI adapts its analysis based on the submission type and SFDA's specific requirements for each pathway.