🇸🇦 ValiPro: SFDA & GCC-Compliant Process Validation Services
Ensure Smooth Product Registration and Rapid Market Entry into the Kingdom of Saudi Arabia (KSA).
ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting Saudi Arabia and the wider Gulf Cooperation Council (GCC) market. Our documentation is built for full compliance with the strict standards of the Saudi Food and Drug Authority (SFDA), including their adherence to global benchmarks like ICH and WHO.
We help manufacturers of Pharmaceuticals, APIs, Cosmetics, Herbal, and Food products secure their SFDA approvals, minimize deficiencies, and navigate the complex GCC regulatory landscape efficiently.
🌟 Why SFDA-Ready Validation is Critical
The Saudi Food and Drug Authority (SFDA) is known for its rigorous enforcement of quality, safety, and efficacy standards, often mirroring US FDA and EU expectations.
Mandatory Quality Data: The SFDA's drug registration dossier (eCTD Module 3) explicitly requires documentation for Process Validation and/or Evaluation (3.2.S.2.5 and 3.2.P.3.4), making compliant protocols and reports non-negotiable for approval.
Verification & Abridged Pathways: SFDA offers accelerated pathways for products approved by US FDA or EMA. Our alignment with these global standards ensures your validation documents meet the prerequisite for using these faster routes.
Inspection Readiness: We prepare documentation that satisfies SFDA's GMP requirements, crucial for facilities seeking to pass necessary on-site or desktop audits (often waived only if the site is approved by a recognized authority like GCC-DR).
🎯 SFDA Compliance Focus: Who We Support
We specialize in supporting international and local manufacturers needing compliance with SFDA requirements, including:
Pharmaceutical & API Exporters: Targeting drug registration via the Saudi Drug Registration (SDR) system and the eCTD format.
Cosmetic & Food Suppliers: Ensuring manufacturing processes are robust, supporting the mandatory Certificate of Conformity (CoC) and compliance with GSO/SFDA Technical Regulations (e.g., GSO 1943/2016 for cosmetics).
Regulatory Responses: Firms addressing SFDA/GCC deficiency letters related to Quality, CMC, and manufacturing process data.
SFDA/GCC-DR GMP Inspection: Preparing comprehensive validation packages required for regulatory inspections.
🛠️ Our SFDA Process Validation Services
Our expertise covers the entire lifecycle of validation documentation, ensuring it is technically sound and regulator-acceptable across the Gulf region.
Preparation of $PV$ Protocols & Reports: Custom-developed documents that adhere to the SFDA's three-stage lifecycle approach (Process Design, Process Qualification, Continued Process Verification).
Gap Assessment (SFDA/GSO): Reviewing your existing validation documents against SFDA Drug Sector Guidelines, PIC/S GMP Guide, and relevant Gulf Standards Organization (GSO) Technical Regulations.
eCTD Module 3 Quality Data: Structuring and presenting validation summaries and data specifically for SFDA's electronic Common Technical Document (eCTD) format.
Query Handling: Expert technical defense and generation of response documents to SFDA assessors' quality and validation inquiries.
📜 Regulatory Standards We Follow
Our documentation is designed to align with the core standards prioritized by the Saudi Food and Drug Authority:
StandardRelevance to SFDA/GCCSFDA Drug Sector GuidelinesDirect compliance with all published Drug Sector requirements, including data presentation and structure.PIC/S GMPSFDA has adopted the PIC/S GMP Guide, making our documentation compliant with their core quality system expectations.ICH Q8, Q9, Q10Alignment with the internationally recognized quality lifecycle principles, which the SFDA emphasizes.GSO Technical RegulationsEnsuring compliance for non-drug products (Cosmetics, Food) with the unified Gulf Standards.US FDA & EU GMPOur high-standard documentation facilitates submission via SFDA's Verification and Abridged pathways.
🤝 Get Started on Your SFDA Validation
Ensure your products clear customs and gain market authorization in Saudi Arabia without avoidable delays.
To receive a Technical Scope and Commercial Proposal tailored for your SFDA submission, simply provide:
Product: Dosage form (e.g., tablet, injectable) and Batch Size
Target SFDA Pathway: (e.g., Regular, Verification, Abridged, Cosmetic Notification)
Manufacturing Process: Overview and critical steps
Timeline: Submission or inspection date
Existing Data: Any current validation documents or SFDA deficiency letters.