GlobalCOA – Malaysia 🇲🇾
Certificate of Analysis (COA) Preparation, Review & Testing Services
Malaysia-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA, a professional service brand of Zoesoe Exports Pvt Ltd, provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Malaysian regulatory requirements for products manufactured, marketed, or exported from Malaysia.
We support Malaysian manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Malaysian Standards (MS) and seamless acceptance in domestic and international markets.
🏛️ Regulatory Framework – Malaysia
GlobalCOA services are aligned with the requirements of key Malaysian regulatory and standards authorities:
National Pharmaceutical Regulatory Agency (NPRA): The key authority under the Ministry of Health (MOH) responsible for regulating the quality, efficacy, and safety of Pharmaceuticals (Drugs), Traditional Medicines, Health Supplements, and Cosmetics under the Control of Drugs and Cosmetics Regulations 1984.
Food Safety and Quality Division (FSQD): The division under the MOH responsible for regulating Food Products and Ingredients under the Food Act 1983 and Food Regulations 1985.
Department of Standards Malaysia (DSM): The National Standards Body, responsible for developing and publishing Malaysian Standards (MS) and promoting standardization and accreditation.
Malaysian Accreditation Body (STANDARDS MALAYSIA): Manages the national accreditation scheme, ensuring testing laboratories are accredited under the Skim Akreditasi Makmal Malaysia (SAMM) (ISO/IEC 17025).
JAKIM (Department of Islamic Development Malaysia): Sets the requirements for Halal Certification (mandatory for many food/cosmetic products), which may impose specific testing for prohibited ingredients.
ASEAN Harmonization: Malaysia adheres to the ASEAN Common Technical Document (ACTD) for pharmaceuticals and common standards for food and cosmetics.
🔬 Our GlobalCOA Services – Malaysia
We offer complete lifecycle support for Certificate of Analysis documentation as per Malaysian regulatory expectations:
✅ COA Preparation (Malaysia-Compliant)
COA drafting aligned with NPRA/MOH requirements (for product registration), Food Regulations 1985 (for food), and applicable Malaysian Standards (MS).
Alignment with ACTD / ASEAN guidelines and international pharmacopoeias (USP / BP / EP) where required for product dossiers or export.
Batch-wise, stability-based, and customer-specific COAs.
COAs suitable for Product Registration (NPRA) and Customs clearance.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for NPRA / FSQD / MS / SAMM compliance.
Identification and correction of non-compliance issues related to:
Missing mandatory parameters (e.g., as per Food Regulations for heavy metals, contaminants).
Incorrect acceptance criteria or test methods.
Compliance with Halal requirements (e.g., alcohol content, animal derivatives).
Harmonization with product specifications, Good Manufacturing Practice (GMP), and registration dossiers submitted to the NPRA.
✅ Testing & Analytical Coordination (Malaysia)
Testing coordination through SAMM-accredited (ISO/IEC 17025) or NPRA/MOH-recognized laboratories.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, EP) for drugs.
Malaysian Standards (MS) / Food Regulations methods for food and other products.
Validated in-house methods with justification.
Support for re-testing and OOS/OOT investigations.
📦 Product Categories Covered – Malaysia
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceuticals & Health Products
APIs, Traditional Medicines, and Health Supplements (regulated by NPRA).
Finished Drug Products.
🔹 Food & Beverages
Processed Food, Food Ingredients, and Nutritional Products (regulated by FSQD/MOH and often requiring Halal compliance).
🔹 Cosmetics & Personal Care
Products regulated under the Control of Drugs and Cosmetics Regulations 1984 (NPRA).
🔹 Industrial & Other Products
Materials requiring mandatory MS certification or quality documentation for trade.
🏭 Industries We Serve – Malaysia
GlobalCOA supports regulated Malaysian industries including:
Pharmaceuticals & Traditional Medicines
Food Processing & Beverage
Cosmetics & Personal Care
Industrial Manufacturing and Trading
🌟 Why Choose GlobalCOA for Malaysia?
**✔ Deep understanding of NPRA and FSQD/MOH requirements.
✔ COAs aligned with Malaysian Standards (MS) and ACTD/ASEAN guidelines.
✔ Strong coordination with SAMM-accredited laboratories.
✔ Documentation suitable for NPRA Product Registration and Halal certification support.
📝 Regulatory & Export Support – Malaysia
GlobalCOA COAs support critical processes in the Malaysian context:
Product Registration applications to the NPRA (Drugs, Cosmetics, Supplements).
Customs clearance and import/export documentation.
Compliance with Food Act 1983 and its regulations.
Supporting documentation for Halal certification submissions (JAKIM).
Our Malaysia-focused COAs reduce regulatory queries and ensure seamless market acceptance across the ASEAN region.
📞 Get Started with GlobalCOA – Malaysia
Whether you require new COA preparation, review of existing COAs, or testing support for Malaysian manufacturing or export batches, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.