QA Support

QA Support–Laying the Foundation

Our team consists of highly qualified and trained subject matter experts. We offer QMS and Clinical QA support to ensure your studies remain compliant. We have in – depth knowledge of global clinical trial regulations.

Supplement your quality team and ensure your adherence to regulatory requirements by conducting risk assessments and implementing continuous improvement initiatives. Our team can help you to d evelop quality policies, standard operating procedures (SOPs), a nd documentation to ensure that every aspect of your therapy aligns with specified requirements .

Quality Assurance Support activities include:

  • SOP Development
  • Creating and Managing Quality Management Systems
  • Addressing Quality events, deviations, incidents, investigations, and reports
  • Oversight of vendor qualification program
  • Internal Audits
  • Attending Study Meetings as a QA representative
  • GxP Training
  • Regulatory Intelligence