GlobalCOA – Peru

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

Peru-Compliant COAs. 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 services in accordance with Peruvian regulatory requirements for products manufactured, imported, marketed, or exported to and from the Republic of Peru.

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

Regulatory Framework – Peru

GlobalCOA services are aligned with the requirements of:

• Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)
• Ministry of Health of Peru (Ministerio de Salud – MINSA)
• National Institute for the Defense of Competition and Protection of Intellectual Property (INDECOPI) (standards, where applicable)
• Peruvian Pharmacopoeia and DIGEMID-accepted international pharmacopoeias
• National Food Safety and Quality Regulations (for food & nutraceuticals)
• Codex Alimentarius (where applicable)
• ISO / internationally accredited testing laboratories

Our GlobalCOA Services – Peru

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

✅ COA Preparation (Peru-Compliant)

• COA drafting as per DIGEMID / MINSA requirements
• Alignment with Peruvian Pharmacopoeia, USP / BP / EP, and Codex where applicable
• Batch-wise, stability-based, and customer-specific COAs
• COAs suitable for sanitary registration, import permits, customs clearance, and export documentation

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for DIGEMID / MINSA compliance
• Identification and correction of:
o Missing mandatory test parameters
o Incorrect specifications or acceptance criteria
o Non-pharmacopoeial or unsupported analytical methods
• Harmonization with product specifications, CTD/ACTD dossiers, DMFs, and registration documents

✅ Testing & Analytical Coordination (Peru)

• Testing through ISO-accredited / DIGEMID-recognized laboratories
• Method selection as per:
o Peruvian Pharmacopoeia / DIGEMID-accepted methods
o National pharmaceutical, cosmetic, and food regulations
o Validated in-house methods with scientific justification
• Support for re-testing, OOS/OOT investigations, trend analysis, and regulatory responses

Product Categories Covered – Peru

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 Peruvian standards

🔹 Finished Products

• Pharmaceutical formulations & APIs
• Cosmetics & personal care products
• Herbal & traditional medicines
• Nutraceuticals, food ingredients, and dietary supplements

🔹 Solvents & Processing Aids

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

Industries We Serve – Peru

GlobalCOA supports regulated industries in Peru including:

• Pharmaceuticals & APIs
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose GlobalCOA for Peru?

✔ Deep understanding of Peruvian sanitary registration and DIGEMID approval processes
✔ COAs aligned with DIGEMID, MINSA & Peruvian Pharmacopoeia
✔ Strong coordination with ISO-accredited laboratories
✔ Export-ready documentation accepted across Peru, Andean Community & global markets
✔ Audit-ready and inspection-friendly COAs
✔ Backed by the regulatory expertise of Zoesoe Exports Pvt Ltd

Regulatory & Export Support – Peru

GlobalCOA COAs support:

• Sanitary registrations and renewals
• Import permits and customs clearance
• Export documentation
• CTD / ACTD / DMF dossier submissions
• Customer, importer, and distributor requirements
• Quality audits and regulatory inspections

Our Peru-focused COAs help reduce authority queries, testing delays, batch rejections, and shipment disruptions.

Get Started with GlobalCOA – Peru

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