Certified Quality Assurance & Global Compliance

GMP & ISO Certified OEM Manufacturer in Malaysia

International Manufacturing Facilities & Business Certifications

ORIZI Group operates state-of-the-art production facilities in Malaysia that comply strictly with international regulatory standards. Our audited management systems guarantee safe, reliable, and compliant contract manufacturing for global cosmetic, food, supplement, and medical device brands.

Good Manufacturing Practice GMP Cosmetics

Cosmetics Good Manufacturing Practice (GMP)

NPRA Ministry of Health Malaysia & ASEAN Directives

Our cosmetic manufacturing plants strictly adhere to ASEAN Cosmetic GMP Guidelines inspected by the National Pharmaceutical Regulatory Agency (NPRA). This ensures rigorous quality control over cleanrooms, equipment calibration, personnel hygiene, and product batch traceability—allowing brand owners to legally register and market skincare and cosmetics across ASEAN and global markets.

Food and Supplement GMP Certification

Food & Nutraceutical GMP (MS 1514)

SIRIM QAS International & Ministry of Health Malaysia

Complies with MS 1514 standards for health food, dietary supplements, and functional beverages. Verified through systematic audits by SIRIM QAS and the Ministry of Health, establishing rigorous contamination prevention, sanitation, and supply chain tracking for B2B global distribution.

ISO 22716 cGMP Certification

ISO 22716:2007 Cosmetic cGMP

International Organization for Standardization

The global benchmark for cosmetic Good Manufacturing Practices recognized throughout the European Union, the United States, and Asia-Pacific. ISO 22716 certification provides comprehensive audit trails covering raw material handling, production, laboratory quality control, packaging, and shipping compliance.

ISO 13485 Medical Devices Certification

ISO 13485:2016 Medical Devices Quality System

Audited by KGS Certification & MDA Compliant

Certified Quality Management System tailored specifically for medical devices. ISO 13485 enforces stringent risk management, process validation, cleanroom environment controls, and biological safety for manufacturing medical gels, diagnostic fluids, and wound care treatments.

ISO 22000 Food Safety System

ISO 22000 Food Safety Management System

SIRIM QAS International & IQNet Accredited

Integrates HACCP principles with international business management systems. ISO 22000 guarantees complete food safety controls throughout our supply chain, hazard prevention, continuous monitoring, and full batch recall readiness for commercial food and supplement exports.

HACCP Certification

HACCP (MS 1480 / Codex Alimentarius)

Preventive Hazard Analysis & Critical Control Points

Systematic preventive protocol ensuring food and supplement formulations are free from biological, chemical, and physical hazards. Recognized globally by international food authorities and major global retail chains for contract manufacturing security.

SA8000 Social Accountability Certification

SA8000 & SEDEX / SMETA Ethical Audits

Social Accountability International & Intertek Audited

Independently audited social compliance standard ensuring fair working hours, health and safety, non-discrimination, and ethical labor standards across our manufacturing hubs. Fully compatible with international corporate ESG procurement criteria.

US FDA Registration Facility

US FDA Facility Registrations (MoCRA & FSMA)

United States Food & Drug Administration Compliance

Registered foreign facilities meeting US MoCRA (Modernization of Cosmetics Regulation Act) standards for cosmetics and FSMA (21 CFR Part 1 Subpart H) requirements for food and dietary supplements, enabling effortless product import into the US market.

Product Quality Certifications & Laboratory Validations

Every formula developed and manufactured by ORIZI Group undergoes rigorous physical, chemical, microbiological, and clinical testing. We support overseas brand owners with all mandatory documentation for rapid clearance in international markets.

JAKIM Halal Certification

JAKIM Halal Certification

Department of Islamic Development Malaysia (MS 2634 & MS 1500)

JAKIM Halal certification is globally recognized as the gold standard in Halal integrity. Our production lines, raw ingredients, equipment, and cleaning procedures comply strictly with MS 2634 (Cosmetics) and MS 1500 (Food), giving your brand immediate trust across ASEAN, Middle East/GCC, and Muslim-majority consumer markets worldwide.

MDA Establishment License Malaysia

MDA Licensed Establishment

Medical Device Authority Malaysia (Act 737)

Officially licensed medical device manufacturer authorized under Malaysian Medical Device Act 2012. Enables contract manufacturing and export of clinical ultrasound gels, conductive gels, surgical lubricants, and scar care products.

Dermatologically Tested Skincare

Dermatological & Clinical Safety Testing

In-Vivo, In-Vitro & Patch Test Approvals

We provide comprehensive clinical evaluation services including Human Repeat Insult Patch Testing (HRIPT), hypoallergenic validation, non-comedogenic studies, and active efficacy claims testing for professional dermatology and luxury skincare formulations.

Biocompatibility Medical Device Testing

Biocompatibility & Efficacy Testing

ISO 10993 & Disinfectant Kill-Rate Standards

Medical devices and antibacterial formulations undergo ISO 10993 cytotoxicity, sensitization, and irritation testing. Disinfectants and sanitizers receive EN-standard microbial kill-rate validations against bacteria, viruses, and fungi.

Certificate of Analysis COA Documentation

Complete Export Documentation & COA

Batch Analysis, MSDS, COO & Certificate of Free Sale

Every commercial production batch is shipped with complete regulatory documentation, including Certificate of Analysis (COA), Safety Data Sheets (MSDS/GHS), Certificate of Origin (COO), and Certificate of Free Sale (COFS) to guarantee fast customs clearance.

FSC Sustainable Packaging Certification

Clean Beauty & Sustainable Standards

FSC Packaging, ECOCERT/COSMOS, Non-GMO & Vegan

Supporting sustainable brands with Forest Stewardship Council (FSC) certified paper packaging, ECOCERT/COSMOS organic raw material sourcing, Non-GMO verification, and 100% cruelty-free, vegan formulation options.

Uncompromising Quality for Overseas Importers

Navigating international health regulations can be complex. ORIZI Group eliminates friction for overseas brand owners by delivering end-to-end regulatory guidance, proven formula safety, and institutional credibility.

Multi-Facility Redundancy 6 specialized companies providing scalable production capacity up to 60,000 units/day.
In-House Analytical Testing Advanced R&D lab conducting real-time stability, viscosity, pH, and microbiological testing.
Global Compliance Turnkey Regulatory assistance for NPRA, US FDA, European CPNP, and Gulf GSO product registrations.
Ethical & Solar Powered SEDEX SMETA audited operations powered by SEDA NEM NOVA industrial solar energy systems.