Do you represent this company?
If YES, Claim your Life Science profile on SOURCE EXPLORER to get connected with top Life Science Professionals.

Supplier Logo


United States


In short, we help bring life-changing innovations to more people, sooner. How we do it is a longer story. It starts with our cloud-based Product Lifecycle Excellence platform. More than 1000 of the world?s most innovative and highly regulated companies use it to improve quality and stay in compliance at every step of their product journey ? from concept to commercialization. We have more than 500 employees who come to work every single day with a singular focus: to help our customers improve quality. We do it in many ways. And we can do it for you. We?ll help you build quality into your product design processes. You?ll get a streamlined system to track clinical trials, organize the data, and submit results for approval by regulatory agencies around the world. You can digitize, automate and accelerate quality processes to build a culture of quality throughout your organization. Increase visibility and ensure compliance throughout your supply chain. And help your manufacturing teams eliminate the tradeoffs between line performance and product quality. Once your product is out in the market we give you the ability to manage in-market complaints and close the quality loop. In other words, we help you make quality a priority throughout your company. And that?s important. Because when you?re trying to impact people?s lives, quality changes everything.

Areas of subspecialty

483 responses
Warning Letter Responses
Remediation Strategies
Labeling and Website Reviews
Audits and Gap Analyses
Mock FDA Inspections
Regulatory Submissions
Areas of service
  • North America