GlobalCOA – Roorkee (Uttarakhand, India)

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

Roorkee-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 Roorkee and the Uttarakhand pharmaceutical & industrial corridor.

We support organizations across Roorkee Industrial Area, SIDCUL Haridwar–Roorkee Belt, Manglaur, Laksar, Bhagwanpur, and nearby manufacturing clusters, ensuring accurate, authority-acceptable, and audit-ready COAs for domestic supply and international exports.

Regulatory Framework Applicable – Roorkee

GlobalCOA services in Roorkee 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)
• Uttarakhand State Drugs Control Department
• NABL / ISO-accredited testing laboratories in Uttarakhand & India

Our GlobalCOA Services – Roorkee

✅ 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 / Uttarakhand State 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 – Roorkee

• Testing coordination through NABL-accredited laboratories in Roorkee, Haridwar & Uttarakhand
• 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 – Roorkee

🔹 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 – Roorkee Region

• Pharmaceuticals & APIs
• Contract Manufacturing Organizations (CMOs)
• Herbal & AYUSH manufacturers
• Nutraceutical & food ingredient producers
• Cosmetics & personal care manufacturers
• Industrial & specialty chemicals

Why Choose GlobalCOA – Roorkee?

✔ Strong understanding of Uttarakhand State FDA & CDSCO expectations
✔ Experience supporting Roorkee–Haridwar SIDCUL manufacturing units
✔ Reliable coordination with Uttarakhand NABL laboratories
✔ Export-ready, inspection-friendly COAs
✔ Reduced regulatory queries, batch rejections & shipment delays

Regulatory & Export Support – Roorkee

GlobalCOA COAs support:

• CDSCO & Uttarakhand State FDA compliance
• Export documentation & customs clearance
• Product registration dossiers
• DMF / CTD submissions
• Customer audits & regulatory inspections

Get Started with GlobalCOA – Roorkee

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

📩 Contact us today to discuss your product category, regulatory pathway, and Roorkee-specific COA requirements.