GlobalCOA – Philippines 🇵🇭

Certificate of Analysis (COA) Preparation, Review & Testing Services

Philippine-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 Philippine regulatory requirements for products manufactured, marketed, or exported from the Philippines.

We support Philippine manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Philippine National Standards (PNS) and seamless acceptance in domestic and international markets.

🏛️ Regulatory Framework – Philippines

GlobalCOA services are aligned with the requirements of key Philippine regulatory and standards authorities:

• Food and Drug Administration (FDA) Philippines: The principal regulatory body under the Department of Health (DOH) responsible for the registration, quality, and safety control of Drugs (Pharmaceuticals), Food, Cosmetics, Medical Devices, and Household Urban Hazardous Substances (HUHS). FDA Certificate of Product Registration (CPR) or Certificate of Product Notification (CPN) is mandatory.

• Bureau of Philippine Standards (BPS): The National Standards Body under the Department of Trade and Industry (DTI) responsible for developing and publishing Philippine National Standards (PNS) and implementing mandatory product certification (PS Mark) for various consumer and industrial products.

• Philippine Accreditation Bureau (PAB): The national body under DTI responsible for accrediting testing laboratories (ISO/IEC 17025) under the Philippine Laboratory Accreditation Scheme (PALAB).

• ASEAN Harmonization: The Philippines adheres to ASEAN Common Technical Document (ACTD) for pharmaceuticals and common standards for food and cosmetics.

• International Pharmacopoeia / Standards: Filipino regulations often reference international standards:

  • USP / BP / EP / Ph. Int.: Referenced for pharmaceutical quality.

  • Codex Alimentarius: Referenced for food safety and quality standards.

🔬 Our GlobalCOA Services – Philippines

We offer complete lifecycle support for Certificate of Analysis documentation as per Philippine regulatory expectations:

✅ COA Preparation (Philippines-Compliant)

• COA drafting aligned with FDA Philippines regulations (for CPR/CPN applications), relevant Philippine National Standards (PNS), and technical regulations (e.g., specific contaminant limits in food).

• Compliance with international pharmacopoeias (USP / BP / EP) and ACTD/ASEAN guidelines for drugs.

• Batch-wise, stability-based, and customer-specific COAs.

• COAs suitable for FDA Product Registration/Notification (CPR/CPN) and BPS Mandatory Certification.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for FDA / BPS / PNS compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory testing parameters (e.g., microbial limits for food, specific heavy metals for cosmetics).

  • Incorrect acceptance criteria or non-approved test methods.

• Harmonization with product specifications and registration dossiers submitted to the FDA.

✅ Testing & Analytical Coordination (Philippines)

• Testing coordination through PAB-accredited (ISO/IEC 17025) or FDA/BPS-recognized laboratories.

• Method selection as per:

  • Relevant Pharmacopoeial methods (USP, BP, EP) or methods recognized under the ACTD for drugs.

  • Philippine National Standards (PNS) / FDA methods or Codex Alimentarius for food and other regulated products.

  • Validated in-house methods with appropriate justification.

• Support for re-testing, OOS/OOT investigations, and quality trend analysis.

📦 Product Categories Covered – Philippines

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

  • APIs, Traditional Medicines, and Health Supplements (regulated by FDA).

  • Finished Drug Products.

• 🔹 Food & Beverages

  • Processed Food, Food Ingredients, and Nutritional Products (regulated by FDA).

• 🔹 Cosmetics & Personal Care

  • Products regulated under FDA Cosmetic Regulations (referencing ASEAN Cosmetic Directive).

• 🔹 Industrial & Other Products

  • Materials requiring mandatory BPS Certification (PS Mark) or compliance with PNS.

🏭 Industries We Serve – Philippines

GlobalCOA supports regulated Philippine industries including:

• Pharmaceuticals & Traditional Medicines

• Food Processing & Beverage

• Cosmetics & Personal Care

• Industrial Manufacturing and Trading

🌟 Why Choose GlobalCOA for the Philippines?

• **✔ Deep understanding of FDA Philippines registration, notification, and quality requirements.

• ✔ COAs aligned with Philippine National Standards (PNS) and ACTD/ASEAN guidelines.

• ✔ Strong coordination with PAB-accredited laboratories.

• ✔ Documentation suitable for CPR/CPN applications and BPS certification.

📝 Regulatory & Export Support – Philippines

GlobalCOA COAs support critical processes in the Philippine context:

• Product Registration/Notification applications (CPR/CPN) to the FDA.

• Customs clearance and import/export documentation.

• Compliance with BPS Mandatory Certification Schemes.

• Supporting documentation for GMP compliance and quality audits.

Our Philippine-focused COAs reduce regulatory delays and ensure seamless access to the local and ASEAN markets.

📞 Get Started with GlobalCOA – Philippines

Whether you require new COA preparation, review of existing COAs, or testing support for Philippine manufacturing or export batches, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.