Hydra Quality & Compliance

Pharma compliance & cold chain solutions — led by quality professionals

Hydra delivers more than products. We deliver assurance. Led by experienced quality and compliance professionals, we provide integrated solutions that help organisations maintain compliance, improve operational performance, and uphold the highest standards of patient and consumer safety.

In Compliance with ISO, WHO, GDP, Patient Safety compliance logos ISO, WHO, GDP, Patient Safety compliance logos ISO, WHO, GDP, Patient Safety compliance logos ISO, WHO, GDP, Patient Safety compliance logos ISO, WHO, GDP, Patient Safety compliance logos
Pharma cleanroom professional

10+

Years of compliance expertise

KSA + UAE

Jeddah HQ

ISO Certified

Standards certified & aligned

GDP GMP Compliant

Ensures safe and secure

Services & Products

Everything HYDRA Offers

Temperature Mapping

Warehouse, cold room, reefer vehicle & freezer mapping — SFDA & WHO GDP compliant.

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Validation & Qualification

IQ/OQ/PQ for cold storage, pharma equipment & warehouses.

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GDP & Regulatory Compliance

SFDA GDP audit readiness, gap assessment & regulatory consulting.

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Monitoring & Data Loggers

SFDA-compliant RTMS, IoT monitoring & pharma data loggers.

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Calibration Services

ISO 17025 calibration — on-site & lab. Jeddah, Riyadh, Dammam, Jubail.

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Pharma QMS

QMS implementation, SOP development, CAPA & gap assessment.

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Thermal Packaging & Shipping

GDP-compliant passive packaging — vaccines, blood samples, pharma.

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Computer System Validation

GAMP 5, 21 CFR Part 11, EU Annex 11. Only Saudi-based CSV provider.

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Cold Chain Solutions

GDP transport compliance, audit readiness & gap assessment — in one place.

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Temperature Data Logger

ISO 17025 calibrated temperature data loggers for pharmaceutical companies

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Why Hydra

Delivering more than Products.
Delivering Assurance

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Patient & Consumer Safety First

Every product, service, and recommendation is evaluated against its impact on patient and consumer safety. This is non-negotiable.

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Led By Quality Professionals

Our team is made up of experienced quality, compliance, and validation professionals — not sales reps. You engage directly with the experts doing the work.

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Global Standards, Local Delivery

Aligned with WHO GDP, EU GDP, USP, FDA requirements, and SFDA regulations — all delivered by a team based in Jeddah, on-site across KSA within 1–2 days.

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ISO 9001 · 14001 · 45001 Certified

HYDRA’s own operations are certified to ISO 9001 (quality management), ISO 14001 (environmental), and ISO 45001 (occupational health & safety).

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Value-Adding, Not Just Compliant

We do not deliver checkbox compliance. Every engagement is designed to add measurable operational value to the organisations we serve.

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Regional Presence — KSA & UAE

Headquartered in Jeddah with offices across KSA and a dedicated Dubai sales and operations team opening in 2026.

Sustainability & Responsibility

Compliance with a Conscience

Environmental Management

ISO 14001 certified operations. We monitor and reduce our carbon footprint across all service delivery and logistics activities.

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Sustainable Cold Chain

Passive thermal packaging reduces energy consumption versus active refrigeration. We help clients choose solutions with lower environmental impact.

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People & Community Safety

ISO 45001 certified. Our team and clients are protected by rigorous occupational health and safety practices on every on-site engagement.

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Partners

Our Trusted Partners

Hydra Quality & Compliance proudly partners with Emball'ISO, Elitech, Strategnos, HTI Polar Bag, and angarin to deliver innovative quality, compliance, packaging, and monitoring solutions. Together, we help organizations achieve regulatory excellence, operational efficiency, and the highest industry standards.

ISO Standards & Global Compliance Alignment

Certified, Accredited, and Globally Aligned

Hydra Compliance Expert pointing to standards

ISO 9001:2015

Quality Management System — the global benchmark for consistent, high-quality products and services.

ISO 14001:2015

Environmental Management System — HYDRA's commitment to minimising environmental impact across all operations.

ISO 45001:2018

Occupational Health & Safety Management — protecting our team and the clients we work with on-site.

ISO 17025:2017

Calibration laboratory accreditation — all calibration certificates are traceable to national and international standards.

WHO GDP & EU GDP

All distribution compliance services are aligned with WHO Good Distribution Practice 2010 and EU GDP guidelines.

USP & FDA Alignment

Services are designed to meet USP (United States Pharmacopeia) standards and FDA requirements for international pharmaceutical clients.

Testimonials

What Our Client Say

Frequently Asked Questions

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Hydra provides specialized quality assurance, temperature mapping, validation and qualification, SFDA GDP regulatory compliance consulting, IoT cold chain monitoring, calibration, computer system validation, and QMS implementation services for the pharmaceutical, biotech, and healthcare sectors.

Hydra works with organizations across various industries, including manufacturing, healthcare, pharmaceuticals, food and beverage, technology, logistics, and other regulated sectors.

We perform gap assessments, design GDP-compliant operations, prepare facilities for SFDA audits, calibrate equipment, qualify storage systems, and implement standard operating procedures (SOPs) based on WHO, EU, and local regulatory guidelines.

Hydra supports and is aligned with ISO 9001, ISO 14001, ISO 45001, ISO 17025, WHO Good Distribution Practices (GDP), EU GDP guidelines, USP, FDA alignment, and local SFDA requirements.