GMP Services
GMP Manufacturing Services
cGMP-compliant manufacturing for diagnostic, clinical, and commercial life science products.
FDA-Registered cGMP Facility
Enzo’s FDA-registered manufacturing facility operates under current Good Manufacturing Practice (cGMP) guidelines. Our ISO 13485-certified quality management system ensures consistent, high-quality production of reagents, kits, and components for the diagnostics and pharmaceutical industries.
GMP Manufacturing Capabilities
End-to-end manufacturing solutions under strict quality controls
Reagent Manufacturing
Large-scale production of buffers, substrates, conjugates, and assay reagents under cGMP conditions
Kit Assembly
Complete diagnostic kit assembly including component manufacturing, packaging, and labeling
Quality Control Testing
Comprehensive QC/QA programs including incoming material testing, in-process controls, and final release testing
Regulatory Documentation
Full documentation packages including DMFs, validation protocols, stability studies, and regulatory submissions support
Bulk Manufacturing
Scale-up from R&D to commercial volumes with validated processes and full traceability
Validation Services
IQ/OQ/PQ validation, method validation, and process validation following FDA guidance
Quality Management System
Our quality management system is built on a foundation of regulatory compliance and continuous improvement:
- FDA-registered manufacturing facility (21 CFR Part 820)
- ISO 13485:2016 certified quality management system
- cGMP compliance for in-vitro diagnostic products
- Full lot traceability from raw materials to finished goods
- Environmental monitoring and clean room facilities
- Validated analytical methods and equipment
- Document control and change management systems
- CAPA (Corrective and Preventive Action) program
Industries Served
- In-vitro diagnostics (IVD) manufacturers
- Pharmaceutical and biopharmaceutical companies
- Clinical reference laboratories
- Point-of-care testing companies
- Veterinary diagnostics
- Food safety testing
Partner with Our GMP Team
Discuss your manufacturing requirements with our GMP specialists. We offer flexible engagement models from project-based to long-term supply agreements.