GlobalCOA – United Kingdom (UK)

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

UK-Compliant COAs. MHRA-Ready. Import & 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 in accordance with United Kingdom regulatory requirements for products manufactured in the UK or imported into / exported from the UK.

We support UK manufacturers, importers, exporters, distributors, CMOs, and international brand owners with accurate, compliant, and authority-acceptable COAs, ensuring smooth MHRA acceptance and global market approval.

Regulatory Framework – United Kingdom

GlobalCOA services are aligned with the requirements of:

Medicines and Healthcare products Regulatory Agency (MHRA)
United Kingdom Pharmacopoeia (BP – British Pharmacopoeia)
European Pharmacopoeia (Ph. Eur.) (where referenced by MHRA)
UK Health Security Agency (UKHSA)
Department for Environment, Food & Rural Affairs (DEFRA) (for food-related products)
UK Good Manufacturing Practice (UK GMP)
UKAS / ISO/IEC 17025-accredited testing laboratories

Our GlobalCOA Services – United Kingdom

We provide complete lifecycle support for Certificate of Analysis documentation in line with UK regulatory expectations:

COA Preparation (UK-Compliant)

• COA drafting as per MHRA, British Pharmacopoeia (BP), and applicable Ph. Eur. / USP standards
• Alignment with USP / EP / IP for export and parallel-trade products
Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for:
– MHRA marketing authorisation dossiers
– UK import release & QP certification
– Export shipments
– Distributor, tender, and partner submissions

COA Review & Regulatory Compliance Assessment

• Review of existing COAs for MHRA / UK GMP compliance
• Identification and correction of:
– Missing mandatory parameters
– Incorrect specifications or acceptance limits
– Unsupported non-pharmacopoeial test methods
• Harmonization with:
– Product specifications
UK-CTD / eCTD dossiers
– DMFs / ASMFs
– Manufacturing authorisations and batch documentation

Testing & Analytical Coordination – United Kingdom

• Testing coordination through UKAS-accredited and MHRA-recognized laboratories
• Method selection based on:
– British Pharmacopoeia (BP)
– European Pharmacopoeia (Ph. Eur.)
– USP / ICH-aligned methods
– Validated in-house methods with scientific justification
• Support for:
– Re-testing and verification
OOS / OOT investigations
– Trend analysis and MHRA responses

Product Categories Covered – United Kingdom

GlobalCOA provides COA services across key regulated product categories:

🔹 Raw Materials

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

🔹 Packaging Materials

• Primary pharmaceutical packaging
• Secondary and tertiary packaging
Food-contact and cosmetic-contact materials (UK-compliant)

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Biotechnology & biologics products
• Advanced therapy medicinal products (ATMPs)
• Cosmetics & personal care products
• Nutraceuticals, food ingredients, and dietary supplements

🔹 Solvents & Processing Aids

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

Industries We Serve – United Kingdom

GlobalCOA supports regulated industries across the UK, including:

• Pharmaceuticals & APIs
• Biotechnology & Life Sciences
• Vaccines & biologics manufacturing
• Contract Manufacturing Organisations (CMOs)
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Specialty & Industrial Chemicals

Why Choose GlobalCOA for the United Kingdom?

✔ Strong understanding of MHRA & UK GMP expectations
✔ COAs aligned with BP, Ph. Eur. & ICH guidelines
✔ Seamless coordination with UKAS-accredited laboratories
Import-ready and export-ready COAs
✔ Audit-ready, inspection-friendly documentation
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – United Kingdom

GlobalCOA COAs support:

• MHRA product registrations & lifecycle variations
• UK import release & QP certification
• Export documentation for EU, US & global markets
• UK-CTD / eCTD & DMF submissions
• Distributor, partner, and tender requirements
• MHRA inspections and quality audits

Our UK-focused COAs help reduce regulatory queries, prevent batch delays, and ensure uninterrupted market access.

Get Started with GlobalCOA – United Kingdom

Whether you require new COA preparation, review of existing COAs, or testing coordination for products manufactured in or exported from the United Kingdom, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted UK compliance partner.

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