World-Class QA/QC and Global Accreditations - Ensuring Quality, Compliance & Trust. USFDA approved facilities with comprehensive regulatory compliance across global standards.
We uphold stringent Quality Management Systems (QMS) with full compliance to global regulatory standards—including USFDA, EMA, WHO, ANVISA, CDSCO, ICH, Saudi GMP, and more. Accredited across multiple divisions and fully certified, we commit to data integrity and best-in-class operational excellence.
Certification / Compliance | Scope |
|---|---|
| USFDA approvals | Across analytical labs and manufacturing sites |
| WHO GMP | Certified for quality system adherence |
| NABL accreditation | Analytical and bioanalytical lab testing |
| GLP certification | For bioanalytical labs |
| ISO Certifications | • ISO 14001 (Environmental) • ISO 45001 (Occupational Health & Safety) • ISO 50001 (Energy) Environmental stewardship and safety systems |
| 21 CFR Part 11 compliance | Ensures data integrity for digital documentation/systems |
Our labs are outfitted with advanced instrumentation and environments for rigorous quality control:
HPLC (UV/FLD/DAD), GC (FID), LC-MS, FTIR, particle counters, electrophoresis units, PCR/RT-PCR systems, ELISA, Karl Fischer, TOC, microscopes, stability chambers (-20 °C to 40 °C/high humidity), and more
GLP-compliant bioanalytical and QC labs, with appropriate classified zones, controlled temperature and humidity, and wide-ranging analytical capabilities—handling chemical, molecular biology, microbiology, bioassay, and stability-DP testing
Labs regularly audited and approved by USFDA, CDSCO, ANVISA, EMA, MHRA, enhancing global trust for developmental and submission purposes
Comprehensive QA/QC systems and documentation packages ready for regulatory audits
Comprehensive CoAs and validated analytical reports meeting international standards
Verified stability and method validation dossiers for regulatory submissions
Secure, digitally compliant data and training records (Docuzen, Eduzen, Qualzen)
Our comprehensive quality systems and global accreditations ensure that every product we develop and manufacture meets the highest standards of quality, safety, and efficacy. With zero tolerance for data integrity breaches and robust digital systems, we provide our partners with complete confidence in our quality assurance processes.
World-Class Quality Standards
USFDA Approved • WHO GMP Certified • NABL Accredited • ISO Certified • 21 CFR Part 11 Compliant
