GlobalCOA – India 🇮🇳

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

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

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

🏛️ Regulatory Framework – India

GlobalCOA services are aligned with the requirements of:

• Central Drugs Standard Control Organization (CDSCO): The National Regulatory Authority (NRA) for Pharmaceuticals, APIs, and certain Medical Devices, enforcing the Drugs & Cosmetics Act, 1940.

• Indian Pharmacopoeia Commission (IP): Publishes the Indian Pharmacopoeia (IP), the official standard for drugs manufactured and marketed in India.

• Food Safety and Standards Authority of India (FSSAI): Regulates food products, nutraceuticals, and food ingredients under the Food Safety and Standards Act, 2006.

• Ministry of AYUSH: Regulates Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy products, enforcing specific quality guidelines.

• Bureau of Indian Standards (BIS): The National Standards Body, setting Indian Standards (IS) for thousands of industrial and consumer products, including chemicals and certain packaging materials.

• NABL / ISO-accredited testing laboratories: Ensures that testing is conducted by laboratories accredited under the National Accreditation Board for Testing and Calibration Laboratories (NABL) or international equivalents.

🔬 Our GlobalCOA Services – India

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

✅ COA Preparation (India-Compliant)

• COA drafting as per Indian Pharmacopoeia (IP), BIS standards, FSSAI regulations, and AYUSH guidelines.

• Alignment with global standards like USP / BP / EP where required for export.

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

• COAs suitable for manufacturing license applications, Export NOC, and registration dossiers.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for IP / CDSCO / FSSAI / AYUSH compliance.

• Identification and correction of:

  • Missing mandatory parameters.

  • Incorrect acceptance criteria.

  • Non-pharmacopoeial test justifications.

• Harmonization with product specifications, CTD dossiers, Drug Master Files (DMFs), and license documents.

✅ Testing & Analytical Coordination (India)

• Testing through NABL-accredited laboratories.

• Method selection as per:

  • Indian Pharmacopoeia (IP).

  • BIS / FSSAI methods.

  • Validated in-house methods with justification.

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

📦 Product Categories Covered – India

GlobalCOA provides COA services for:

• 🔹 Raw Materials

  • APIs and pharmaceutical actives.

  • Excipients.

  • Herbal, botanical, and Ayurvedic raw materials.

  • Chemical intermediates.

• 🔹 Packaging Materials

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

  • Food-contact and cosmetic-contact materials as per BIS / FSSAI norms.

• 🔹 Finished Products

  • Pharmaceutical formulations & APIs (CDSCO).

  • Cosmetics & personal care products.

  • Herbal & Ayurvedic formulations (AYUSH).

  • Nutraceuticals, food ingredients, and supplements (FSSAI).

• 🔹 Solvents & Processing Aids

  • Residual and recovery solvents.

🏭 Industries We Serve – India

GlobalCOA supports regulated Indian industries including:

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts (AYUSH)

• Food & Nutraceutical Ingredients (FSSAI)

• Essential Oils & Fragrances

• Agrochemicals

• Industrial Chemicals (BIS)

🌟 Why Choose GlobalCOA for India?

• ✔ Deep understanding of Indian regulatory requirements (CDSCO, FSSAI, AYUSH, BIS).

• ✔ COAs aligned with IP, CDSCO, FSSAI, AYUSH & BIS.

• ✔ Strong coordination with NABL / ISO laboratories.

• ✔ Export-ready documentation accepted globally.

• ✔ Audit-ready and inspection-friendly COAs.

• ✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd.

📝 Regulatory & Export Support – India

GlobalCOA COAs support:

• Manufacturing license applications.

• Export documentation & customs clearance.

• Product registrations and renewals.

• DMF / CTD dossier submissions.

• Customer, importer, and distributor requirements.

• Quality audits and regulatory inspections.

Our India-focused COAs reduce regulatory queries, batch rejections, and shipment delays.

📞 Get Started with GlobalCOA – India

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