As regulators get tougher on enforcement, a proactive approach to quality and regulatory compliance can ensure sustained success.
To meet today’s heightened demands, prevention is key. Our consulting team – an unmatched combination of former Ministry of Health officials experts – has helped more than 100 pharmaceutical firms develop effective regulatory strategies and strengthen quality systems to create competitive advantage.
Integrated regulatory compliance and quality management yield lasting benefits
Regulatory strategy – integrated solutions with local expertise
GMP and cGMP compliance and risk mitigation
Quality system design and optimization
Regulatory compliance remediation – track record of successful resolution of Warning Letters and establishing foundations for sustained compliance
Regulatory & Quality Perspectives :
The Art of Compliance
Robust Audit Programs
The Patient is Waiting – Quality's Quiet Impact on the Public Trust