Regulatory & Compliance Consulting

Take a proactive approach through partnership

Partnering with Quintiles' global group of industry experts and former officials can facilitate smoother, more efficient processes in risk mitigation or compliance remediation.

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Optimize your regulatory and quality performance

Quintiles focuses on effective regulatory strategies and strengthening quality systems to create competitive advantage.

Compliance with rigorous regulation standards demands collaboration

To meet increased demands and evolving requirements, planning and prevention are essential in a global environment. When you join forces with a team of industry experts, you can lay the right foundation for sustained compliance and effective regulatory strategies.

A coordinated effort leads to competitive advantage

Quintiles offers an unmatched combination of industry leaders and former FDA/EMA officials who help biopharma, medical device and biotech firms effectively address regulatory and compliance challenges.

  • Regulatory strategy – integrated solutions based on global and local expertise in 60+ countries.
  • GCP, GLP, GMP and cGMP compliance and risk mitigation.
  • Quality system design and optimization.
  • Regulatory compliance remediation – a track record of successful resolution of warning letters and establishing foundations for sustained compliance.

The power of possibilities

At Quintiles, we never underestimate the vast number of variables and human factors involved in the delivery of 100% quality and safety that is expected from FDA-approved products.

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