Quality Assurance and Regulatory Compliance

Up-to-the-minute compliance? Yes. Our team of industry professionals understand the ever changing regulatory landscape and has the expertise to ensure the highest levels of compliance.

Accreditations Across the Board

  • VAWD Accredited
  • cGMP Compliant - 21 CFR 210, 211, 820
  • State & DEA Licensed and FDA Registered
  • ISO 13485

Advanced Quality Management System

  • Commercial Launch Support
  • Customized Work Instructions
  • Training and Document Control
  • Serialization and Pedigree
  • Drug Supply Chain Security Act Compliance
  • Recall Management
  • Returns and Reverse Logistics Management
  • Fully Validated Space
  • Audit Programs