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REGULATORY, QUALITY & COMPLIANCE

Reactive compliance is not sustainable. To move to a strategy of quality and compliance that is forward-thinking, efficient, and effective, you need experts. We’ll train your team, set up audits and assessments, and validate your processes and equipment to make sure they’re in compliance with your local, national, and international legislative bodies.

Regulatory compliance tracking, regular compliance auditing, and validation of processes by a third party helps keep your company FDA compliant.

From GxP employee training and procedures to system change documentation and CAPAs being closed in a timely manner, we will ensure your compliance program is operating at peak performance.

  • Quality and Compliance Strategy
  • Audits and Assessments
  • Remediation
  • Validation and Qualification
  • CSV, CSA, Process, Equipment
  • Cloud Assurance
  • SOP Assessment and Development
  • Global Product Identification
  • Global Unique Device Identification (UDI)
  • EU MDR / IVDR strategy and implementation
  • Data Integrity
  • GxP Training and Education
  • Managed Services and Staff Augmentation
  • And many more customized regulatory compliance services