Compliance & accreditation
Quality is not a department at Apex Evergreen — it is the foundation of everything we make. Every product, from every facility, is held to the requirements of the world's most demanding regulatory authorities.
Our accreditations
World Health Organization GMP
The global baseline for pharmaceutical manufacturing quality. All 21 of our facilities operate under WHO Good Manufacturing Practice guidelines, ensuring consistent product safety, efficacy, and quality across every batch we produce.
US Food & Drug Administration
Multiple Apex Evergreen facilities hold active USFDA approvals — meeting the requirements of one of the world's most stringent regulatory jurisdictions and enabling compliant supply to the United States.
European GMP Certification
Our EU-GMP certified facilities meet the rigorous quality requirements of the European Medicines Agency, providing the gateway to pharmaceutical supply across EU member states.
Pharmaceutical Inspection Co-operation Scheme
Held by several of our facilities, PIC/S represents one of the most comprehensive international frameworks for pharmaceutical inspection — validating our quality systems against globally harmonised standards.
Our approach
Quality at Apex Evergreen is not a final checkpoint — it is engineered into every stage, from the sourcing of raw materials to the release of finished product. The same rigorous systems and culture of accountability run through all 21 facilities, so that wherever a product is made, it meets one uncompromising standard.
Comprehensive QMS governing every stage of manufacturing, from raw material to finished product.
In-house quality control and analytical testing to international pharmacopoeial standards.
Full documentation and traceability ensuring every batch meets specification.
A culture of continuous improvement and readiness for inspection by any global regulator.
Validated cold-chain and containment capabilities for sensitive biologicals and specialised products.
Dedicated quality assurance and control professionals across our facilities.
Regulatory approvals
Beyond our global accreditations, Apex Evergreen holds country-specific regulatory approvals and product registrations across more than 80 markets — from Latin America and Sub-Saharan Africa to the Gulf, the CIS region, Southeast Asia, and Europe. Each approval reflects a national regulator's independent verification of our quality.
Why it matters
For the distributors, licensors, and health systems we serve, our quality and compliance are more than credentials — they de-risk supply, unlock market access, and provide the confidence to build long-term partnerships on a foundation that regulators worldwide have independently verified.
Reliable supply
Consistent, specification-meeting product, batch after batch.
Market-ready dossiers
Registrations and documentation prepared for the markets you serve.
Audit-backed confidence
Quality systems validated by the world's most demanding regulators.
Trusted worldwide
From accreditation to market approval, our quality is the foundation your supply can stand on.