HomeQuality & Compliance

Quality & Regulatory
Compliance

Every JMS operation is built on a foundation of regulatory excellence — SFDA-licensed, ISO-certified, and GDP-compliant at every stage of the supply chain.

Certifications that Define Our Standard

JMS holds all mandatory and voluntary certifications required to operate the highest-quality pharmaceutical distribution in Saudi Arabia.

SFDA Distribution License

Saudi Food & Drug Authority

Full pharmaceutical wholesale distribution license issued by the Saudi Food and Drug Authority — covering all product categories including controlled substances.

Active License

ISO 9001:2015

International Organization for Standardization

Quality Management System certification confirming that JMS's operations meet international standards for process excellence, consistency, and continuous improvement.

Certified & Current

GDP Compliance

Good Distribution Practice Guidelines

Full compliance with EU GDP guidelines adopted by SFDA — covering personnel, premises, equipment, documentation, operations, complaints, returns, and outsourced activities.

Fully Compliant

Cold Chain Validation

WHO / IATA Standards

All cold rooms and refrigerated vehicles validated through WHO-standard temperature mapping studies with documented protocols and qualified systems.

Validated

Narcotics & Controlled Substances

Ministry of Health — KSA

Licensed to store and distribute narcotics, psychotropics, and controlled substances under strict MOH regulatory oversight with dedicated vault storage.

Licensed

Health & Safety Certification

Civil Defense & OSHA Standards

All facilities comply with Saudi Civil Defense requirements and OSHA-aligned health and safety standards for pharmaceutical warehousing operations.

Compliant

Our Quality Commitments

JMS's quality policy is anchored in five fundamental commitments that govern every aspect of pharmaceutical handling and distribution.

"Quality is not an action, it is a habit. At JMS, every process, every decision, and every delivery reflects our unwavering commitment to patient safety and regulatory excellence."

JMS Quality Management

Patient Safety First

Every quality decision prioritizes the safety and wellbeing of the patients who ultimately depend on the products we distribute.

Full Regulatory Compliance

Proactive engagement with all SFDA requirements, guidelines, and amendments to maintain full licensure and compliance at all times.

Continuous Improvement

Regular internal audits, KPI monitoring, deviation management, and CAPA systems drive ongoing operational improvement.

Trained & Qualified Personnel

All staff receive GDP, cold-chain, and quality training — with qualified persons overseeing all regulated activities.

Effective Recall Capability

Track-and-trace systems enable rapid, batch-level product recall from the entire distribution network within hours.

Pharmacovigilance

Dedicated pharmacovigilance processes ensure timely reporting of adverse events, quality complaints, and product defects to manufacturers and SFDA.

GDP Compliance Framework

JMS's GDP framework covers all 12 chapters of EU Good Distribution Practice guidelines as adopted by SFDA.

01
Quality Management

QMS, quality policy, and documented procedures

02
Personnel

Qualified persons, training & competence

03
Premises & Equipment

Facility design, calibration & maintenance

04
Documentation

SOPs, records & audit trails

05
Operations

Receipt, picking, dispatch & delivery

06
Complaints & Returns

Complaint handling & return logistics

07
Falsified Medicines

Track-and-trace & verification systems

08
Outsourced Activities

3PL oversight & quality agreements

09
Self-Inspections

Internal audit programme & CAPA

10
Transportation

Cold-chain transport validation & monitoring

11
Controlled Substances

Narcotics handling & security protocols

12
Risk Management

ICH Q9-aligned risk assessment & controls

Cold-Chain Management

Temperature-sensitive pharmaceuticals demand absolute precision. JMS operates fully validated cold-chain infrastructure from manufacturer receipt to final delivery.

Our cold rooms are built to WHO and SFDA standards, validated through temperature mapping studies, and equipped with IoT monitoring devices transmitting data continuously to our central control system. Every cold-chain vehicle carries calibrated monitoring devices with real-time data availability.

From receipt of biologics and vaccines to last-mile delivery, no product leaves our facilities without verified temperature integrity.

2–8°C Validated Storage

Refrigerated zones for biologics, vaccines, insulin & APIs

15–25°C Controlled Ambient

Climate-controlled zones for controlled room temperature products

Continuous Data Loggers

IoT sensors with automated alarms & redundant backup systems

Refrigerated Delivery Fleet

SFDA-compliant vehicles with real-time temperature monitoring

GDP-Compliant Cold Rooms

Fully validated infrastructure meeting SFDA & EU-GDP standards

Excursion Alert System

Instant escalation protocols to prevent any temperature deviation

Cold-Chain by the Numbers

End-to-end validated cold chain across all 12 warehouses and the delivery fleet.

100%
Monitoring Coverage
24/7
Real-Time Alerts
WHO
Validated Standard
SFDA
RSD Track & Trace

Partner with Confidence.
Distribute with Assurance.

JMS's compliance infrastructure gives pharmaceutical manufacturers the regulatory certainty they need to succeed in the Saudi market.