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

GlobalCOA – Worldwide

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

Export-Ready COAs. Regulatory-Aligned. Globally Trusted.

GlobalCOA, a professional service brand of Zoesoe Exports Pvt Ltd, provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in compliance with global regulatory requirements for products manufactured, marketed, or exported worldwide.

We support manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring regulatory acceptance, smooth exports, and seamless market entry across international jurisdictions.

Global Regulatory Framework Alignment

GlobalCOA services are aligned with requirements of major international and national regulatory authorities, including but not limited to:

Pharmaceutical & Healthcare Authorities

• US FDA

• EMA & EU National Competent Authorities

• MHRA (UK)

• Health Canada

• TGA (Australia)

• CDSCO (India)

• ASEAN Drug Regulatory Authorities

• GCC MOH Authorities

• LATAM & ROW Health Authorities

Food, Nutraceutical & Consumer Product Authorities

• FSSAI (India)

• US FDA (Food & Dietary Supplements)

• EFSA (EU)

• Codex Alimentarius

• ASEAN Food Authorities

• GCC Food Control Authorities

Cosmetics & Personal Care

• EU Cosmetic Regulation (EC 1223/2009)

• US FDA (Cosmetics)

• ASEAN Cosmetic Directive

• GCC Standardization Organization (GSO)

• National cosmetic authorities (ROW)

Standards & Testing Bodies

• USP, BP, EP, IP, JP

• ISO, FCC, BIS

• NABL / ISO 17025 accredited laboratories

Our GlobalCOA Services – Worldwide

✅ COA Preparation (Regulatory & Export-Compliant)

• COA drafting as per USP, BP, EP, IP, JP, FCC, ISO, Codex, BIS

• Country- and market-specific COA formats for:

  • US, EU, UK, ASEAN, GCC, LATAM, Africa & ROW

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

• COAs suitable for:

  • Product registration dossiers

  • Export shipments & customs clearance

  • DMF / CTD / ACTD / ASEAN CTD submissions

✅ COA Review & Regulatory Compliance Assessment

• Technical review of existing COAs for:

  • Pharmacopoeial compliance

  • Country-specific regulatory expectations

• Identification and correction of:

  • Missing mandatory parameters

  • Incorrect limits or acceptance criteria

  • Inconsistent test methods or units

• Harmonization with:

  • Product specifications

  • CTD dossiers & DMFs

  • Stability data & validation reports

✅ Testing & Analytical Coordination (Global)

• Testing support through NABL / ISO 17025 accredited laboratories

• Method selection as per:

  • Pharmacopoeial methods

  • Regulatory-approved methods

  • Validated in-house methods with justification

• Support for:

  • Re-testing & method transfer

  • OOS / OOT investigations

  • Trend analysis & regulatory responses

Product Categories Covered – Global

🔹 Raw Materials

• APIs & pharmaceutical actives

• Excipients

• Herbal, botanical & natural raw materials

• Chemical intermediates & additives

🔹 Packaging Materials

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

• Secondary & tertiary packaging

• Food-contact & cosmetic-contact materials

🔹 Finished Products

• Pharmaceutical formulations & APIs

• Cosmetics & personal care products

• Herbal & Ayurvedic formulations

• Nutraceuticals, food ingredients & supplements

🔹 Solvents & Processing Aids

• Residual & recovery solvents

• Cleaning & processing solvents

• Industrial & laboratory solvents

Industries We Serve – Global

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Nutraceuticals & Food Ingredients

• Essential Oils & Fragrances

• Agrochemicals

• Industrial & Specialty Chemicals

Why Choose GlobalCOA (Worldwide)?

✔ Deep understanding of global regulatory expectations
✔ COAs aligned with pharmacopoeial & country-specific standards
✔ Strong coordination with accredited testing laboratories
✔ Export-ready documentation accepted across multiple markets
✔ Audit-ready, inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Global Regulatory & Export Support

GlobalCOA COAs support:

• Product registrations & renewals

• Export documentation & customs clearance

• DMF / CTD / ACTD submissions

• Importer, distributor & customer requirements

• Regulatory audits, inspections & due diligence

Our globally harmonized COAs reduce regulatory queries, shipment delays, and batch rejections.

Get Started with GlobalCOA – Worldwide

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

📩 Contact us today to discuss your product, target countries, and COA requirements.

“Regulatory-Compliant Certificates of Analysis for Global Markets”

Excellence in Certificates of Analysis Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Certificate of Analysis (COA) preparation, review, and testing coordination services

1. What is GlobalCOA?

GlobalCOA is a professional service brand of Zoesoe Exports Pvt Ltd that provides end-to-end Certificate of Analysis (COA) preparation, review, and testing coordination services for products supplied to regulated global markets.

2. Which countries and regions does GlobalCOA support?

GlobalCOA supports worldwide markets, including USA, EU, UK, ASEAN, GCC, LATAM, Africa, India, and ROW. COAs are prepared and reviewed as per country-specific regulatory and pharmacopoeial requirements.

3. Which regulatory standards are followed for COA preparation?

GlobalCOA prepares and reviews COAs in alignment with:

• USP, BP, EP, IP, JP

• FCC, ISO, Codex

• Country-specific regulatory guidelines (FDA, EMA, CDSCO, FSSAI, AYUSH, GCC MOH, ASEAN, etc.)

4. What types of COA services does GlobalCOA provide?

We provide:

• COA Preparation (new, batch-wise, stability-based, customer-specific)

• COA Review & Compliance Assessment

• Testing & Analytical Coordination

• COA correction, upgrading, and harmonization for exports

• Support for regulatory queries, OOS/OOT, and re-testing

5. Which product categories are covered under GlobalCOA?

GlobalCOA covers:

• APIs, excipients & pharmaceutical raw materials

• Finished pharmaceutical products

• Cosmetics & personal care products

• Herbal, Ayurvedic & botanical products

• Nutraceuticals & food ingredients

• Packaging materials

• Solvents & processing aids

• Industrial & specialty chemicals

6. Can GlobalCOA prepare export-ready COAs for FDA, EU, ASEAN, and GCC markets?

Yes. GlobalCOA prepares export-ready, regulator-acceptable COAs suitable for FDA, EU, ASEAN, GCC, LATAM, and ROW submissions, customs clearance, and importer requirements.

7. Do you also review existing COAs issued by manufacturers or labs?

Yes. We perform technical and regulatory reviews of existing COAs to identify:

• Missing mandatory parameters

• Incorrect limits or acceptance criteria

• Non-aligned test methods

• Inconsistencies with specifications, dossiers, or DMFs

8. Does GlobalCOA conduct laboratory testing?

GlobalCOA coordinates testing through NABL / ISO 17025–accredited laboratories. We do not operate in-house labs but ensure testing is performed using regulator-acceptable, validated methods.

9. Can you support OOS / OOT investigations related to COA results?

Yes. GlobalCOA provides documentation and coordination support for:

• OOS (Out of Specification)

• OOT (Out of Trend)

• Re-testing justification

• Trend analysis and regulatory explanations

10. Are GlobalCOA COAs suitable for CTD / DMF submissions?

Absolutely. Our COAs are designed to align with:

• CTD / eCTD / ACTD dossiers

• DMF submissions

• Product registration and variation filings

11. Can GlobalCOA customize COAs as per importer or customer format?

Yes. We prepare customer-specific and importer-specific COA formats while ensuring full regulatory compliance.

12. Do you support both domestic and export batches?

Yes. GlobalCOA supports domestic market compliance as well as international export batches, ensuring seamless transition between local and global regulatory expectations.

13. How fast is the turnaround time for COA services?

Turnaround time depends on:

• Product category

• Testing requirements

• Target market

• Data availability

However, GlobalCOA is known for fast, export-focused, and audit-ready documentation.

14. Which industries benefit most from GlobalCOA services?

GlobalCOA supports:

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal & Ayurvedic products

• Nutraceuticals & Food Ingredients

• Essential Oils & Fragrances

• Agrochemicals & Industrial Chemicals

15. Why should companies choose GlobalCOA?

✔ Global regulatory expertise
✔ Export-ready, authority-acceptable COAs
✔ Strong accredited lab network
✔ Multi-industry experience
✔ Reduced regulatory queries and shipment delays
✔ Backed by Zoesoe Exports Pvt Ltd’s compliance expertise

16. How can we get started with GlobalCOA?

Simply contact us with:

• Product details

• Target country/market

• Testing status (available / required)

📩 Our team will guide you on the exact COA pathway needed for compliance and export.