GlobalCOA – Bhutan 🇧🇹

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

Bhutan-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 Bhutanese regulatory requirements for products manufactured, marketed, or exported from Bhutan.

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

🏛️ Regulatory Framework – Bhutan

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

• Bhutan Food and Drug Authority (BFDA): The primary and merged regulatory body responsible for safeguarding public health through the regulation of Food, Medicines, Narcotics, and Agricultural Products. (Formed by merging the former Drug Regulatory Authority (DRA), Bhutan Narcotics Control Authority (BNCA), and Bhutan Agriculture and Food Regulatory Authority (BAFRA)).

  • Medical Product Division (MPD): Regulates medical products (drugs, traditional medicines, health supplements).

  • Food Quality and Safety Division (FQSD): Ensures the safety and quality of food products.

  • Certification and Standard Service (CSS): Provides product certification and compliance with national standards.

• Bhutan Standards Bureau (BSB): The National Standards Body, responsible for developing and publishing Bhutan Standards (BTS), operating product testing infrastructure, and product/management system certification schemes.

• National Food Testing Laboratory (NFTL): The official laboratory under the BFDA (formerly BAFRA) for testing food and related products.

• International Pharmacopoeia / Standards: Requirements for testing and documentation may reference international standards like BP / USP / EP for pharmaceuticals, or Codex Alimentarius for food, especially for export.

🔬 Our GlobalCOA Services – Bhutan

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

✅ COA Preparation (Bhutan-Compliant)

• COA drafting aligned with BFDA regulations (for Medical Products and Food), and applicable Bhutan Standards (BTS).

• Alignment with international standards like USP / BP / EP or Codex Alimentarius where required for product registration or export.

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

• COAs suitable for Product Registration (BFDA-MPD/FQSD), import/export permits, and commercial documentation.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for BFDA / BSB / BTS compliance.

• Identification and correction of:

  • Missing mandatory parameters (e.g., as per BFDA/BTS specifications).

  • Incorrect acceptance criteria.

  • Non-pharmacopoeial or non-standard test justifications.

• Harmonization with product registration dossiers, technical specifications, and license documents.

✅ Testing & Analytical Coordination (Bhutan)

• Testing coordination through BFDA/BSB-recognized laboratories (including the National Food Testing Laboratory - NFTL) or internationally accredited labs.

• Method selection as per:

  • Pharmacopoeial methods (BP, USP, etc.) for drugs.

  • Bhutan Standards (BTS) / BFDA methods for food and other products.

  • Validated in-house methods with justification.

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

📦 Product Categories Covered – Bhutan

GlobalCOA provides COA services for regulated sectors:

• 🔹 Medical Products (Drugs & Supplements)

  • APIs and pharmaceutical actives.

  • Allopathic, Traditional, and Health Supplement formulations (regulated by BFDA-MPD).

  • Excipients and raw materials.

• 🔹 Food & Nutraceuticals

  • Food products, ingredients, and supplements (regulated by BFDA-FQSD).

  • Agro-processed products.

• 🔹 Other Products & Materials

  • Products where Bhutan Standards (BTS) or BFDA Certification applies.

  • Packaging and food-contact materials.

🏭 Industries We Serve – Bhutan

GlobalCOA supports regulated Bhutanese industries including:

• Pharmaceuticals & Traditional Medicines

• Food Processing & Nutraceuticals

• Herbal, Natural Extracts & Agro-Products

• Trading and Export-Import businesses handling regulated goods

🌟 Why Choose GlobalCOA for Bhutan?

• **✔ Deep understanding of the Bhutan Food and Drug Authority (BFDA) structure and requirements.

• ✔ COAs aligned with Bhutan Standards (BTS) and BFDA guidelines.

• ✔ Strong coordination with BFDA-recognized and internationally accredited laboratories.

• ✔ Export-ready documentation for global trade.

📝 Regulatory & Export Support – Bhutan

GlobalCOA COAs support critical processes in the Bhutanese context:

• Product Registration applications (BFDA-MPD/FQSD).

• Certification and Standard Service (CSS) compliance.

• Import/Export documentation and customs clearance.

• Quality audits and regulatory inspections by BFDA.

Our Bhutan-focused COAs reduce regulatory risk and facilitate smoother market access.