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ISO 9001 & ISO 13485 Certified

Regulatory & Quality Systems

Regulatory and Quality Systems

Trust and performance are the key decision points for companies looking for their outsourcing partner. Quality is essential, as is uncompromised deliverability and repeatability.

  • Documentation, labeling, testing and supply chain exposure assessment and management mitigates critical regulatory and compliance issues.
  • Outsourcing quality control, certification and testing provides greater assurance in validations and audits.

Regulatory Alignment
  • ISO 9001 Certified with Design Control
  • ISO 13485 Certified with Design Control
  • FDA registered as a manufacturer of In Vitro Diagnostics & a handler of pharmaceutical intermediates

  • Quality Management System
  • Full Traceability
  • Change Control
  • FDA Level Document Control
  • Environmentally Monitored Production Processes
  • Environmentally Controlled Production & Warehouse Facilities
  • Method, Product, Process Validation Capabilities
  • Corrective & Preventative Action System
  • Continual Improvement System
  • Non-Animal Origin (NAO) Control

  • Analytical & Custom Quality Control Specifications
  • Multi-compendial Testing
  • Material Certification
  • Sensitive Analytical Testing
  • Chromatography
  • ICP
  • FTIR
  • Titration
  • Spectrophotometric Testing
  • Bioburden Testing
  • Endotoxin Testing
  • Custom Functional & Performance Assays
  • Material Origin Control
  • Full Lot Traceability
  • Products Tested & Retained