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Quality assurance and quality control

A robust quality system is at the core of your drug development program because your processes and procedures must hold up to the scrutiny of a regulatory inspection. Envigo has a staff of quality gurus to make sure you have the appropriate standard operating procedures (SOPs), working processes and systems in place to ensure your quality imperatives are being followed. Our quality experts make sure you take appropriate steps to maintain the integrity of your study data, and to help you make adjustments and pull your systems back in line in the face of deviations and things outside of your normal processes and procedures.

Do you know what inspectors look for? We do. At Envigo, we have the confidence to make these claims because we employ a team of quality assurance professionals who will work with you to establish and manage a robust quality system.

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  • Core SOP and standard form writing and maintenance
  • Development of internal quality management systems
  • Continuous improvement initiatives
  • Auditing services:
    •    CRO Systems
    •    Laboratory
    •    Clinical study phase GCP site
    •    Vendors
    •    Internal systems
    • Trial master file
  • Inspection readiness training
  • Assistance with completion of MHRA compliance report
  • Disaster recovery and business continuity planning
  • Quality control (QC) of documentation

Avista and Envigo press release

The future of inhaled medications and inhalation technology

[Webinar] De-risking drug development: in vitro strategies that add value to your molecule