Quality Assurance for Drug Developers

Mitigate risks and ensure compliance in your development program

Drug developers face numerous challenges, including regulatory hurdles, increasing pressure to reduce time-to-market, and balancing costs and resources while maintaining quality. However, the likelihood of reaching the market increases with the right quality processes in clinical development.

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Our quality assurance services cover developing and implementing quality systems, conducting audits, and ensuring compliance with regulatory requirements.


Our team of experienced quality assurance professionals can help you identify and mitigate risks, implement best practices, and optimize your operations to ensure quality and compliance. We also provide training and support to help your team maintain a culture of quality throughout your organization.

What we do

  • Design, review, and update of quality management systems.
  • Support personnel training on Standard Operating Procedures (SOPs) and work procedures.
  • Perform vendor assessments before contracting and continuously during the trial.
  • Managing quality oversight via regular meetings, including performance and issue reviews with vendors.
  • Review and approve study documentation created by vendors.
  • Support training of company and Clinical Research Organisation (CRO) personnel in Good Clinical Practice (GCP) and study procedures.
  • Regular review of protocol deviations, adverse events and monitoring reports.
  • Participate in external audits and inspections, as well as support with issue resolution if needed.


Contact our director of Clinical Project Management

Send your inquiry to Maria Fernström

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