We offer a unique “80/20” perspective in regard to quality systems and compliance. You don’t need perfect compliance when you are trying to get to market for the first time. Here’s what one CEO said:
“Cerulean was a true partner. John was instrumental in guiding the development of a FDA compliant quality system from ground zero in record time. This was accomplished in an environment of limited resources and rapidly changing processes. Through it all, he was a delight to work with and always brought more to the table than we were expecting.
– Thomas Kerry McCarter, CEO, Newport News, Virginia
Whether you need a compliance infrastructure built from scratch or just incremental improvements to your environment, Cerulean can provide you the expertise, the confidence, and the support to ensure your success. Start by reviewing the following resources:
- Build Compliance for Personalized Medicine from BioProcess International
- Bottom Line Compliance for Biotechnology: Six Secrets from the Journal of Commercial Biotechnology
- Recorded Seminar & Resource Kit: Effective Oversight of Compliance & Quality Systems for Senior Executives – SOP and Policy Oversight