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QUALITY & COMPLIANCE

Uncompromising Quality Standards
& Regulatory Compliance

Supporting global pharmaceutical formulation with complete batch traceability, Certificate of Analysis (COA) verification, and DMF regulatory documentation.

Quality Assurance

Stringent Manufacturing Audits & Analytical Batch Control

At Mettle Chem, quality assurance is an active operational discipline embedded into every stage of our trading workflow. For our Pharma APIs and Intermediates, we partner exclusively with audited manufacturing facilities adhering strictly to cGMP, ISO, and WHO guidelines. For our Scrap Commodities division, we implement rigorous ISRI grade sorting, moisture limits, and chemical composition testing.

"Our capabilities bridge technical depth and commercial agility. We provide complete regulatory documentation — including batch-specific COAs, DMF regulatory coordination, MSDS, and pre-shipment quality verification."

cGMP & ISO Audited Manufacturing Plants
Batch-Specific COA with Impurity Profiles
DMF Dossier Coordination & Registration Support
Standardized ISRI Commodity Grade Verification
Quality Assurance Showcase

Standard Technical Documentation Provided

Every pharmaceutical API and intermediate supplied by Mettle Chem comes backed by complete regulatory and analytical packages.

Documentation Services

Comprehensive Compliance Support

We ensure that all regulatory, analytical, and technical documentation requirements are fulfilled smoothly.

Quality-Focused Sourcing

Pre-qualification audits of manufacturing sites, vendor evaluation, and initial sample validation.

COA (Certificate of Analysis)

Detailed analytical reports covering assay, purity, impurities profile, and physical parameters.

DMF Coordination

Assistance with Drug Master File availability and regulatory submission readiness.

Technical Documentation

Provision of MSDS, Specification Sheets, Stability Data, and Method of Analysis.

Supplier Coordination

Regular facility monitoring, audit follow-ups, and raw material batch reservation.

Documentation & Logistics

Strict compliance with Dangerous Goods (DG) packing regulations, customs, and climate-controlled shipping.

Quality Workflow

Our 4-Step Quality Control Process

1
Supplier Audit

Rigorous evaluation of manufacturing facility cGMP & ISO certifications.

2
Analytical Verification

Batch COA testing and verification against USP/EP/BP standards.

3
Packaging Inspection

Sealed tamper-proof drum and pallet packaging quality checks.

4
Traceable Dispatch

Door-to-door shipment tracking with full documentation dossiers attached.

Need Technical COA or Regulatory DMF Assistance?

Request a complete analytical specification package for your target API or chemical.