GlobalCOA – Nepal 🇳🇵

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

Nepal-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 Nepalese regulatory requirements for products manufactured, marketed, or exported to or from Nepal.

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

🏛️ Regulatory Framework – Nepal

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

• Department of Drug Administration (DDA): The primary authority under the Ministry of Health and Population (MoHP) responsible for the regulation of Drugs (Pharmaceuticals), Cosmetics, and Health Supplements under the Drug Act 2035 (1978).

• Department of Food Technology and Quality Control (DFTQC): The key authority under the Ministry of Agriculture and Livestock Development (MoALD) responsible for regulating Food Products, Beverages, and Ingredients under the Food Act, 2023 (or previous versions).

• Nepal Bureau of Standards and Metrology (NBSM): The National Standards Body, responsible for developing and publishing mandatory and voluntary Nepalese Standards.

• Nepal Accreditation System (NAS): The official body for accrediting testing laboratories (ISO/IEC 17025, etc.).

• International Pharmacopoeia / Standards: Nepalese regulations, particularly for pharmaceuticals, heavily reference international standards:

  • BP / USP / EP / IP: Referenced for pharmaceutical quality.

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

🔬 Our GlobalCOA Services – Nepal

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

✅ COA Preparation (Nepal-Compliant)

• COA drafting aligned with DDA requirements (for Drug/Cosmetic Registration, Import License), DFTQC Regulations (for food), and mandatory Nepalese Standards set by NBSM.

• Compliance with international pharmacopoeias (IP / USP / BP / EP) for drugs and Codex standards for food.

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

• COAs suitable for DDA Product Registration, Import Licenses, and DFTQC market approval.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for DDA / DFTQC / NBSM compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory testing parameters (e.g., heavy metals for Ayurvedic/Herbal drugs, microbial limits for food).

  • Incorrect acceptance criteria or non-approved test methods.

• Harmonization with product specifications and registration dossiers submitted to the DDA/DFTQC.

✅ Testing & Analytical Coordination (Nepal)

• Testing coordination through NAS-accredited (ISO/IEC 17025) or internationally recognized laboratories.

• Method selection as per:

  • Relevant Pharmacopoeial methods (IP, BP, USP) for drugs.

  • Nepalese Standards / DFTQC 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 – Nepal

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

  • APIs, Finished Drugs, and Excipients (regulated by DDA).

  • Ayurvedic/Herbal Medicines, and Health Supplements.

• 🔹 Food & Beverages

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

• 🔹 Cosmetics & Personal Care

  • Products regulated under the Drug Act 2035 (DDA).

• 🔹 Industrial & Other Products

  • Materials requiring mandatory Nepalese Standards compliance.

🏭 Industries We Serve – Nepal

GlobalCOA supports regulated industries targeting the Nepalese market, including:

• Pharmaceuticals & APIs Suppliers

• Food & Beverage Exporters/Manufacturers

• Cosmetics & Personal Care Suppliers

• Ayurvedic and Herbal Product Producers

• Trading and Export-Import businesses

🌟 Why Choose GlobalCOA for Nepal?

• **✔ Deep understanding of DDA and DFTQC requirements, which are crucial for market entry.

• ✔ COAs aligned with major international standards (IP/BP/USP/Codex) and NBSM Standards.

• ✔ Strong coordination with NAS-accredited and international laboratories.

• ✔ Documentation suitable for DDA Registration and DFTQC Approvals.

📝 Regulatory & Export Support – Nepal

GlobalCOA COAs support critical processes in the Nepalese context:

• Product Registration applications to the DDA (Drugs, Cosmetics) and DFTQC (Food).

• Import License applications and customs clearance.

• Compliance with Nepalese Standards and technical regulations.

• Supporting documentation for GMP compliance and quality assurance.

Our Nepal-focused COAs reduce regulatory delays and ensure smooth market access across the border and internationally.

📞 Get Started with GlobalCOA – Nepal

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