GlobalCOA – United States

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

US-Compliant COAs. FDA-Ready. Audit-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 United States regulatory requirements for products manufactured, imported, marketed, or exported to and from the United States of America.

We support manufacturers, importers, exporters, FDA registration holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with US regulations and seamless acceptance in domestic and international markets.

Regulatory Framework – United States

GlobalCOA services are aligned with the requirements of:

• U.S. Food and Drug Administration (US FDA)
• Code of Federal Regulations (21 CFR – Parts 210, 211, 600, 820, 111, 117, etc.)
• United States Pharmacopeia (USP–NF)
• FDA Guidance Documents & Compliance Policies
• FDA cGMP & cGLP requirements
• ISO / FDA-recognized / cGMP-compliant testing laboratories

Our GlobalCOA Services – United States

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

✅ COA Preparation (US-Compliant)

• COA drafting as per US FDA & 21 CFR requirements
• Alignment with USP–NF, FDA monographs, and ICH guidelines
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for FDA registration, product listing, import clearance, ANDA/NDA support, and export documentation

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for FDA / USP / cGMP compliance
• Identification and correction of:
o Missing mandatory FDA-required parameters
o Incorrect specifications or acceptance criteria
o Non-validated or non-justified analytical methods
• Harmonization with product specifications, CTD dossiers, DMFs, stability data, and quality agreements

✅ Testing & Analytical Coordination (United States)

• Testing through FDA-recognized, ISO-accredited, and cGMP-compliant laboratories
• Method selection as per:
o USP–NF / FDA monographs
o ICH Q2 (R1/R2) validated methods
o Validated in-house methods with full FDA justification
• Support for re-testing, OOS/OOT investigations, data integrity reviews, and FDA responses

Product Categories Covered – United States

GlobalCOA provides COA services for a wide range of regulated product categories:

🔹 Raw Materials

• APIs and pharmaceutical actives
• Excipients
• Herbal, botanical, and natural raw materials
• Chemical intermediates

🔹 Packaging Materials

• Primary packaging (vials, bottles, blisters, ampoules, closures)
• Secondary and tertiary packaging
• Food-contact and cosmetic-contact materials as per FDA & CFR requirements

🔹 Finished Products

• Pharmaceutical formulations & APIs
• OTC & prescription drug products
• Cosmetics & personal care products
• Dietary supplements & nutraceuticals
• Food ingredients & additives

🔹 Solvents & Processing Aids

• Residual and recovery solvents
• Cleaning and processing solvents
• Industrial and laboratory solvents

Industries We Serve – United States

GlobalCOA supports regulated industries in the US including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Cosmetics & Personal Care
• Dietary Supplements & Nutraceuticals
• Food & Beverage Ingredients
• Essential Oils & Fragrances
• Chemicals & Specialty Materials

Why Choose GlobalCOA for the United States?

✔ Deep understanding of US FDA and 21 CFR requirements
✔ COAs aligned with USP–NF, FDA guidance & cGMP expectations
✔ Strong coordination with FDA-recognized laboratories
✔ Import-ready and export-ready documentation
✔ Audit-ready for FDA inspections & client audits
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – United States

GlobalCOA COAs support:

• FDA registration & product listing
• US import clearance & customs support
• ANDA / NDA / DMF dossier submissions
• Dietary supplement & food compliance
• Customer, importer, and distributor requirements
• FDA inspections, audits, and quality investigations

Our US-focused COAs help reduce FDA observations, import alerts, batch rejections, and shipment delays.

Get Started with GlobalCOA – United States

Whether you require new COA preparation, review of existing COAs, or FDA-compliant testing support for products destined for the United States, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.