🇸🇾 ValiPro: Syrian MOH & WHO GMP Process Validation Services

Achieve Compliance and Secure Drug Registration with the Syrian Ministry of Health (MOH) / National Drug Control Center (NDCC).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Syrian market. Our documentation is built for full compliance with the requirements of the Syrian Ministry of Health (MOH) and the National Drug Control Center (NDCC), which heavily rely on WHO Good Manufacturing Practices (GMP) Guidelines.

We specialize in supporting manufacturers of human medicines, veterinary medicines, and medical supplies, helping them secure NDCC approvals, minimize review deficiencies, and successfully register their products in Syria.

🌟 Why Syrian MOH-Ready Validation is Crucial

The Syrian MOH/NDCC regulates all pharmaceutical products entering the market, requiring stringent quality and safety standards.

• WHO GMP Reliance: The Syrian regulatory framework primarily adopts and enforces WHO GMP guidelines. This means your validation documentation must align with WHO's expectations for quality system and process control.

• Dossier Requirement: Product registration in Syria mandates a comprehensive dossier. Validation reports for critical processes (sterilization, aseptic processing, manufacturing) form a crucial part of the Quality Module submission to the NDCC.

• Site Inspection: For foreign manufacturers, the Syrian MOH/NDCC conducts, or requires proof of, GMP certification. Our WHO-compliant validation packages support a successful inspection outcome and demonstrate robust quality assurance.

🎯 MOH/NDCC Compliance Focus: Who We Support

We support manufacturers and their local agents in Syria who need compliance with the following:

• Pharmaceutical & API Exporters: Targeting human and veterinary drug registration with the NDCC.

• Manufacturers: Requiring WHO GMP conformance for manufacturing, cleaning, and analytical validation.

• Regulatory Responses: Addressing deficiency letters or quality queries issued by the Syrian MOH/NDCC assessors regarding manufacturing process controls and capability.

• Supply of Documentation: Need for ready-to-use, regulator-accepted templates and SOPs that align with Syrian requirements.

🛠️ Our Syrian MOH Process Validation Services

We provide complete, scientifically sound, and document-intensive support to meet the MOH/NDCC's specific expectations for quality data.

ServiceSyrian MOH/NDCC FocusPVP & PVR PreparationCustom protocols and reports structured to address WHO GMP (TRS) validation principles, including the demonstration of process capability and control.Analytical ValidationPreparation of detailed Analytical Method Validation Reports to ensure testing procedures meet international and local standards.Dossier IntegrationStructuring validation data to be easily incorporated into the NDCC's required submission format for the Quality Module.Gap AssessmentReviewing current validation procedures against the adopted WHO GMP and any specific Syrian regulatory guidance.Query HandlingProviding expert technical defense and drafting responses to quality and validation queries from NDCC assessors.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards prioritized by the Syrian Ministry of Health:

• WHO Technical Report Series (TRS): The foundational benchmark for GMP and validation compliance in Syria.

• ICH Q8, Q9, Q10: Alignment with these global principles ensures that the process lifecycle approach is acceptable, demonstrating a modern, risk-based approach to validation.

• US FDA Process Validation Guidance: Used as a reference for advanced technical depth, which aids in gaining regulatory confidence.

• EU GMP Guidelines & Annexes: Relevant for manufacturers seeking to demonstrate compliance with high-tier global standards accepted by the MOH.

🤝 Get Started on Your Syrian MOH Validation

Ensure your process validation documentation is robust and immediately acceptable to the Syrian MOH/NDCC, securing your necessary approvals and market access.

To receive a Technical Scope and Commercial Proposal tailored for your Syrian project, simply provide:

• Product: Dosage form (e.g., tablet, injectable) and Batch Size

• Target NDCC Category: (e.g., Human Drug, Veterinary Drug, Medical Supply)

• Target Status: New Registration / Renewal / Site Inspection Support

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or MOH deficiency letters.