GlobalCOA – Bangladesh 🇧🇩

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

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

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

🏛️ Regulatory Framework – Bangladesh

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

• Directorate General of Drug Administration (DGDA): The primary authority for Pharmaceuticals (Drugs), Active Pharmaceutical Ingredients (APIs), and, following the Drug and Cosmetics Act 2023, also for Cosmetics.

• Bangladesh Food Safety Authority (BFSA): The central body for regulating and monitoring the safety of Food, Nutraceuticals, and food-grade ingredients.

• Bangladesh Standards and Testing Institution (BSTI): The National Standards Body, responsible for formulating and issuing Bangladesh Standards (BDS) and granting Certification Marks for numerous products, including food, cosmetics, and industrial chemicals.

• Bangladesh Accreditation Board (BAB) / International Accreditation: Coordination with accredited testing laboratories, including those with BAB accreditation or international recognition like ISO/IEC 17025.

• Bangladesh Agro-Processors' Association (BAPA): (Relevant for the agro-processed food sector, advocating for standards.)

🔬 Our GlobalCOA Services – Bangladesh

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

✅ COA Preparation (Bangladesh-Compliant)

• COA drafting aligned with DGDA (for Drugs/Cosmetics) / BFSA (for Food) / BSTI Standards (BDS), and the latest regulatory acts and rules (e.g., Drug and Cosmetics Act 2023).

• Alignment with global standards like USP / BP / EP where required for export to specific international markets.

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

• COAs suitable for manufacturing license applications, API Source Validation (DGDA), export documentation, and product registration dossiers.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for DGDA / BFSA / BSTI / BDS compliance.

• Identification and correction of:

  • Missing mandatory parameters (e.g., as per BDS).

  • Incorrect acceptance criteria.

  • Non-pharmacopoeial test justifications.

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

✅ Testing & Analytical Coordination (Bangladesh)

• Testing through BAB-accredited (or equivalent international/recognized) laboratories.

• Method selection as per:

  • Pharmacopoeial methods (e.g., BP, USP, Ph.Int., or IP if specified).

  • BSTI Standards (BDS) / BFSA methods.

  • Validated in-house methods with justification.

• Support for re-testing, Out-of-Specification (OOS) / Out-of-Trend (OOT) investigations, and trend analysis.

📦 Product Categories Covered – Bangladesh

GlobalCOA provides COA services for regulated sectors:

• 🔹 Raw Materials

  • APIs and pharmaceutical actives (DGDA Source Validation support).

  • Excipients.

  • Herbal, botanical, and Unani/Ayurvedic raw materials (aligned with DGDA where applicable).

  • Chemical intermediates.

• 🔹 Packaging Materials

  • Primary packaging (bottles, blisters, tubes, liners).

  • Food-contact and cosmetic-contact materials as per BSTI / BFSA norms.

• 🔹 Finished Products

  • Pharmaceutical formulations & APIs (regulated by DGDA).

  • Cosmetics & Personal Care products (regulated by DGDA since 2023).

  • Herbal & Ayurvedic formulations.

  • Nutraceuticals, food ingredients, and supplements (regulated by BFSA/BSTI).

• 🔹 Solvents & Processing Aids

  • Residual and recovery solvents.

  • Cleaning and processing solvents.

🏭 Industries We Serve – Bangladesh

GlobalCOA supports regulated Bangladeshi industries including:

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Unani, Ayurvedic & Natural Extracts

• Food & Nutraceutical Ingredients (including those under BAPA members)

• Industrial Chemicals (where BSTI standards apply)

🌟 Why Choose GlobalCOA for Bangladesh?

• ✔ Deep understanding of DGDA, BFSA, and BSTI requirements.

• ✔ COAs aligned with Bangladesh Standards (BDS) and the new Drug and Cosmetics Act 2023.

• ✔ Strong coordination with BAB-accredited laboratories.

• ✔ Export-ready documentation accepted globally.

• ✔ Audit-ready and inspection-friendly COAs.

📝 Regulatory & Export Support – Bangladesh

GlobalCOA COAs support critical processes in the Bangladeshi context:

• API Source Validation with DGDA.

• Manufacturing and Import/Export license applications (DGDA/CCIE).

• Export documentation & customs clearance (e.g., for non-preferential CO/Origin requirements).

• Product registrations and renewals (DGDA, BSTI, BFSA).

• Customer, importer, and distributor requirements.

Our Bangladesh-focused COAs reduce regulatory hurdles, batch rejections, and shipment delays in the region.