Quality & Compliance For Continuous Improvement
Pharmaceutical Quality; GxP Training, Consulting and Auditing Services
Pharmaceutical Remediation and Quality Systems Compliance
Have A Question? Get In Touch
Helping you with regulatory compliance is the core of our expertise. Our global team of pharmaceutical consultants includes former U.S. FDA and UK MHRA inspectors and experts with decades of experience helping companies to develop strategic plans and address enforcement action.
Take advantage of our learning resources to help you fix and future proof your organization.
For the latest regulatory updates and resources download our pharma app.
U.S FDA/EMA Regulatory Inspection and Enforcement Trends
Why not focus on prevention? Lynne Byers and Jenny Yu from Munich Re Group compare regulatory findings from the U.S. FDA and the EMA. They provide insight into emerging trends from both agencies and highlight the important questions managers need to ask to stay in compliance.
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
Why Do Successful Pharma Companies Have The Edge?
Our EDGE toolkit can help improve GMP and business performance. Find out how your pharma business is performing across multiple sites and departments by bringing your quality systems into sharp focus.
A Beginner’s Guide To Quality Risk Management (QRM)
The pharmaceutical industry approach to assessing and controlling quality risks has largely been empirical. This is often fine but in more complex or hazardous situations, the pharmaceutical industry could benefit from a number of very helpful tools and techniques.
> > Discover more