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.
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.