Quality is not a department at Cooper Life Sciences — it is the Company's DNA. Every product is manufactured under a comprehensive Quality Management System (QMS) that governs all stages: from raw material qualification and in-process testing to batch release and post-market stability surveillance.
Regulatory Framework
- India GMP — Revised Schedule M (2023) fully implemented
- WHO-GMP standards inherited from Cooper Group
- ISO 9001:2015 Quality Management System
- FSSAI Licensed nutraceutical manufacturer
- ICMR / AYUSH nutraceutical guidelines compliant
- FSSC 22000 Food Safety Certification (in progress)
- Export documentation for 30+ country regulatory systems
QC Laboratory Capabilities
- HPLC, UV-Vis Spectrophotometer, Karl Fischer Titration
- Dissolution testing — USP Apparatus I & II
- Microbiological testing lab with LAF workstations
- ICH Zone IVb stability chambers (40°C / 75% RH)
- Certificate of Analysis (CoA) for every batch
- Third-party verification by NABL-accredited labs
- Full batch traceability from raw material to dispatch
Our Capabilities & Services
Contract Manufacturing
Full B2B contract manufacturing for nutraceutical brands, hospital supply chains, and institutional buyers — with complete IP protection and batch confidentiality.
Private Labelling
End-to-end private-label solutions: formulation development, regulatory filing, artwork and packaging design through to finished product supply.
Export Documentation
Experienced regulatory team providing ACTD/CTD dossiers, product registrations, CoA and GMP certificates for international markets.
Formulation Development
In-house R&D developing novel nutraceutical formulations, combination products and customised therapeutic health supplements.