GlobalCOA – Canada
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.
📩 Contact us today to discuss your product category, US FDA regulatory pathway, and COA requirements.
Canada
Below is the complete country-specific conversion of your content, fully tailored to Canada’s regulatory framework, authorities, and Health Canada–aligned compliance expectations, while preserving the same structure, tone, and export-focused positioning as your India master document.
GlobalCOA – Canada
Certificate of Analysis (COA) Preparation, Review & Testing Services
Canada-Compliant COAs. Health Canada-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 Canadian regulatory requirements for products manufactured, imported, marketed, or exported to and from Canada.
We support manufacturers, importers, exporters, market authorization holders, distributors, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Canadian regulations and seamless acceptance in Canada, North America, and global markets.
Regulatory Framework – Canada
GlobalCOA services are aligned with the requirements of:
• Health Canada
• Health Products and Food Branch (HPFB)
• Therapeutic Products Directorate (TPD)
• Natural and Non-prescription Health Products Directorate (NNHPD)
• Canadian Food Inspection Agency (CFIA)
• Food and Drugs Act & Regulations
• Canadian GMP (GUI-0001)
• Canadian Pharmacopoeia / USP / BP / EP (as accepted)
• ISO / Health Canada-recognized testing laboratories
Our GlobalCOA Services – Canada
We offer complete lifecycle support for Certificate of Analysis documentation as per Health Canada regulatory expectations:
✅ COA Preparation (Canada-Compliant)
• COA drafting as per Health Canada GMP & regulatory requirements
• Alignment with USP / BP / EP / Canadian-accepted pharmacopoeias
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for market authorization, import clearance, GMP compliance, and export documentation
✅ COA Review & Regulatory Compliance Assessment
• Review of existing COAs for Health Canada / GMP compliance
• Identification and correction of:
o Missing mandatory parameters
o Incorrect specifications or acceptance criteria
o Non-validated or unsupported analytical methods
• Harmonization with product specifications, CTD dossiers, DMFs, stability files, and quality agreements
✅ Testing & Analytical Coordination (Canada)
• Testing through ISO-accredited / Health Canada-recognized laboratories
• Method selection as per:
o Canadian GMP & pharmacopoeial standards
o Health Canada guidance documents
o Validated in-house methods with scientific and regulatory justification
• Support for re-testing, OOS/OOT investigations, trend analysis, and authority responses
Product Categories Covered – Canada
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 Canadian regulations
🔹 Finished Products
• Pharmaceutical formulations & APIs
• OTC & prescription drug products
• Natural Health Products (NHPs)
• Cosmetics & personal care products
• Nutraceuticals, food ingredients, and supplements
🔹 Solvents & Processing Aids
• Residual and recovery solvents
• Cleaning and processing solvents
• Industrial and laboratory solvents
Industries We Serve – Canada
GlobalCOA supports regulated industries in Canada including:
• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Natural Health Products (NHPs)
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Industrial & Specialty Chemicals
Why Choose GlobalCOA for Canada?
✔ Deep understanding of Health Canada regulatory & GMP requirements
✔ COAs aligned with Health Canada, CFIA & Canadian GMP standards
✔ Strong coordination with ISO-accredited laboratories
✔ Import-ready and export-ready documentation
✔ Audit-ready for Health Canada inspections & partner audits
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd
Regulatory & Export Support – Canada
GlobalCOA COAs support:
• Market authorization & licensing
• Import permits and customs clearance
• Export documentation
• CTD / DMF dossier submissions
• Customer, importer, and distributor requirements
• Health Canada inspections, GMP audits, and quality reviews
Our Canada-focused COAs help reduce regulatory queries, batch rejections, compliance gaps, and shipment delays.
Get Started with GlobalCOA – Canada
Whether you require new COA preparation, review of existing COAs, or Health Canada-compliant testing support for products destined for Canada, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.