Accredited Testing
Every export lot tested at an established ISO/IEC 17025 accredited laboratory before despatch.
Quality & regulatory
Backed by an autonomous quality assurance structure, a state-of-the-art analytical laboratory, and audit-ready documentation designed for seamless, first-time regulatory clearance.
How quality is governed
Standardized testing for uncompromising quality
Our most critical quality assurance decision is to maintain complete independence in testing. All product lots are sampled according to a defined protocol and evaluated by an established, ISO/IEC 17025 accredited third-party laboratory. This ensures that final shipping decisions rely entirely on objective, unbiased data rather than internal interests. The release and rejection protocols are strictly evidence-based.
- ISO Certified certified quality management system covering the warehouse and our contract manufacturing.
- Written specifications agreed up fronts for pharmaceutical grades, including documented clean-down between hazard classes.
- 25+ Countries food-safety system governing food and technical grade manufacture, with HACCP plans per product family.
- Retention samples held for every lot for three years beyond retest date, available for customer investigation.
- Change control with prior notification — no unannounced change to process, site, raw-material source or specification.
Quality Assurance
How every lot is checked
We work with an established ISO/IEC 17025 accredited laboratory. Accreditation means the method, the equipment and the analyst are all audited by a independent body.
Systematic Protocol
Lot-specific results against the agreed specification, issued with every consignment.
Safety Data Sheet
Residual-solvent determination to USP <467> and ICH Q3C class 1, 2 and 3 limits.
Agreed Specification
Anion profiling — chloride, sulphate, nitrate, phosphate — critical where chloride, sulphate or nitrate is the impurity of concern.
Retained Samples
Held against every despatched lot for customer investigation.
Pre-shipment Check
Identity, packing integrity, labelling and document set verified before the container is sealed.
Method details, validation summaries and instrument qualification records are available to customers under confidentiality.
Documentation
The pack that ships with every consignment
QA teams reject more shipments over missing paperwork than over failed analysis. We issue the complete set up front rather than waiting to be asked.
Standard, with every order
- Certificate of Analysis with lot number, manufacturing and retest dates, and all specification parameters with actual results
- Safety Data Sheet in 16-section GHS format, revision-controlled
- Technical Data Sheet with solubility, stability and handling guidance
- Packing list, commercial invoice and transport declaration
Additional documentation as required
- Certificate of Origin and, where required, chamber-legalised or embassy-attested copies
- Allergen, GMO, gluten, BSE/TSE and animal-origin-free declarations
- Elemental impurity statement (ICH Q3D) and residual-solvent statement (ICH Q3C)
- Nitrosamine risk assessment and statement
- Free-sale certificate and ISO certificate for registration filings