Quality & Compliance

Documentation that holds up to any inspection

Quality is not a department here — it is the operating system. Every batch we ship arrives with the paperwork your QA team needs.

GMP Compliance

Suppliers operate under current ICH Q7 GMP. Annual on-site audits, documented quality agreements, and change-control notifications.

ISO Certifications

ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (occupational safety) across our partner network.

Certificate of Analysis (COA)

Batch-specific COA with assay, related substances, residual solvents, and microbial limits — issued for every consignment.

MSDS / SDS Support

GHS-compliant safety data sheets in EN, ES, DE, FR, ZH, and JA — updated to the latest revision standard.

Regulatory Documentation

DMF, CEP, written confirmations, BSE/TSE statements, and elemental impurity assessments delivered to support your filings.

Independent Re-Testing

Optional third-party re-analysis at GLP labs in Europe and India for high-stakes batches.

Audit-ready partners

Regulatory frameworks we operate under

US FDAEU EMAEDQM (CEP)WHO PrequalificationPMDA JapanMHRA UKTGA AustraliaANVISA BrazilCDSCO IndiaNMPA China