Certifications & quality standards
Our quality system, methods, and instrumentation are aligned with internationally recognized standards. Full certificates and method validations are available on request.
Quality Management System
Certified quality management system covering process control, document management, equipment calibration, analyst training, and review.
Standard reference →Good Laboratory Practice
OECD GLP-aligned procedures for non-clinical laboratory studies. Full chain-of-custody, audit trail, and method validation.
Standard reference →Endotoxin (LAL) — Method Validation
Kinetic turbidimetric LAL method validated to USP <85> and EP 2.6.14 acceptance criteria.
Standard reference →Heavy Metals (ICP-MS)
Inductively coupled plasma mass spectrometry validated for elemental impurities to USP <232>/<233>.
Standard reference →Microbial Examination
Method-validated microbial enumeration and specified organism testing for non-sterile products.
Standard reference →Residual Solvents (GC-HS)
GC headspace analysis for residual solvents covering Class 1, 2, and 3 per ICH Q3C(R8).
Standard reference →Need certificate copies for your QA file?
We provide signed copies of our ISO 9001 certificate, GLP attestation, and method validation reports to qualified clients on request. Most QA teams receive documents within one business day.