What makes QxP unique is their expert talent & ability to augment your organization to accomplish your business objectives. They leave your organization stronger. I cannot recommend QxP highly enough.”
Scott Canute, former President Global Manufacturing Eli Lilly and Company and Genzyme Corp., Current Executive Board Director Immunomedics, Inc.
Thank goodness we've had QxP present at (the site) for the past month. We are much better prepared now than we ever would have been on our own. We are not only aware of the issues, but your recommendations for addressing them have been spot on.”
Head of Global Compliance for a Global Company Speaking About a Warning Letter Remediation Support Program
The selection of QxP as the third party expert for our Warning Letter remediation was the best decision we made.”
Senior VP of Operations for a Global Pharmaceutical Company
Regulatory Response and Remediation
Our decades of experience with global regulatory agencies enables us to provide highly successful regulatory communications strategies in partnership with our clients.
We develop strategic responses to complete response letters, 483s, warning letters, consent decrees, and import alerts.
As experts in Quality and Operations, we work with clients to design a holistic remediation plan and quality systems solutions that deliver sustainable results.
Development and Approval Through Commercialization
QxP serves as your bridge to successful commercialization. Through our expertise in analytical methods, validation, quality, manufacturing, and regulatory filings, we ensure submissions meet regulators’ tough standards.
Rapid Onboarding and Workforce Upskilling
QxP partners with you to understand your unique set of organizational challenges. As experts in adult training and education, we develop and implement programs that educate and empower individual employees.
We partner with you to effectively accelerate onboarding and workforce upskilling while incorporating your specific education and training requirements.
Our unique "Twinning" approach ensures that your team develops the skills and capabilities needed to meet your ongoing quality capabilities and commercial demands.
Advanced Therapies, Cell and Gene Scale-Up and Novel Product Launch
The explosive growth of personalized medicine and complex manual processes requires a deep understanding of fundamental aseptic principles and risk management.
Our industry-leading experts provide strategic and practical quality and operational experience.
We focus on providing you with a rapid and reliable path for commercializing your new product.