GlobalCOA – Pune (India)
Certificate of Analysis (COA) Preparation, Review & Testing Services
Pune-Focused COA Support. India-Compliant. 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 coordination services for manufacturers, exporters, traders, and brand owners operating in Pune and the Pune–Chakan–Talegaon industrial belt.
We support organizations across Pimpri-Chinchwad, Chakan, Talegaon MIDC, Ranjangaon, Hinjewadi, Hadapsar, Bhosari MIDC, and nearby manufacturing clusters, ensuring accurate, authority-acceptable, and audit-ready COAs for domestic supply and international exports.
Regulatory Framework Applicable – Pune
GlobalCOA services in Pune are aligned with the requirements of:
• Central Drugs Standard Control Organization (CDSCO)
• Indian Pharmacopoeia Commission (IP)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)
• Maharashtra State Food & Drug Administration (FDA)
• NABL / ISO-accredited testing laboratories in Maharashtra & India
Our GlobalCOA Services – Pune
✅ COA Preparation (India-Compliant)
• COA drafting as per Indian Pharmacopoeia (IP), BIS, FSSAI, and AYUSH requirements
• Alignment with USP / BP / EP for export-oriented products
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for:
– Manufacturing & marketing license compliance
– Export NOCs & customs clearance
– Product registrations & renewals
– Importer and distributor requirements
✅ COA Review & Regulatory Compliance Assessment
• Review of existing COAs for CDSCO / FSSAI / AYUSH / Maharashtra FDA compliance
• Identification and correction of:
– Missing mandatory parameters
– Incorrect specifications or acceptance criteria
– Unsupported non-pharmacopoeial tests
• Harmonization with:
– CTD / ACTD dossiers
– DMFs
– Product specifications
– Manufacturing & export documentation
✅ Testing & Analytical Coordination – Pune
• Testing coordination through NABL-accredited laboratories in Pune & Maharashtra
• Method selection based on:
– Indian Pharmacopoeia (IP)
– BIS / FSSAI methods
– Validated in-house methods with regulatory justification
• Support for:
– Re-testing and verification
– OOS / OOT investigations
– Trend analysis and regulatory responses
Product Categories Covered – Pune
🔹 Raw Materials
• APIs & pharmaceutical actives
• Excipients
• Herbal & botanical raw materials
• Chemical intermediates
🔹 Packaging Materials
• Primary packaging (blisters, bottles, vials, stoppers, tubes)
• Secondary & tertiary packaging
• Food-contact & cosmetic-contact materials
🔹 Finished Products
• Pharmaceutical formulations & APIs
• Cosmetics & personal care products
• Herbal & Ayurvedic formulations
• Nutraceuticals & food supplements
🔹 Solvents & Processing Aids
• Residual & recovery solvents
• Cleaning & processing solvents
• Industrial & laboratory solvents
Industries We Serve – Pune Region
• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Contract Manufacturing Organizations (CMOs)
• Medical devices & allied manufacturing
• Cosmetics & Personal Care
• Herbal, AYUSH & Nutraceutical Products
• Industrial & Specialty Chemicals
Why Choose GlobalCOA – Pune?
✔ Strong understanding of Maharashtra FDA & CDSCO expectations
✔ Experience with Pune, Chakan & Talegaon manufacturing hubs
✔ Reliable coordination with Maharashtra NABL laboratories
✔ Export-ready, inspection-friendly COAs
✔ Reduced regulatory queries, batch rejections & shipment delays
Regulatory & Export Support – Pune
GlobalCOA COAs support:
• CDSCO & Maharashtra FDA compliance
• Export documentation & customs clearance (JNPT & Pune corridor)
• Product registration dossiers
• DMF / CTD submissions
• Customer audits & regulatory inspections
Get Started with GlobalCOA – Pune
Whether you require new COA preparation, review of existing COAs, or testing support for manufacturing or export batches from Pune, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.
📩 Contact us today to discuss your product category, regulatory pathway, and Pune-specific COA requirements.