“Cerulean’s John Avellanet had the knowledge and the real life experience to get our QA system up and running fast. The two most important benefits from our work together were (1) learning how to prioritize and then accomplish the quality and regulatory compliance issues necessary to ensure our survival; and (2) seeing how to take a typical SOP and turn it into a practical, cost-conscious process that streamlined our production environment. Your practical approaches are wonderful.”
– Allan Staley, President, Hampton, Virginia
Whether you’re in a medical device firm or a biopharma company, SOPs serve no purpose when they are comprehensive yet impractical, stringent yet unfollowed. With this client, we saved them $0.5 million (USD) in four months by assessing the right level of compliance needed for their business, and then working with them to implement practical quality and regulatory affairs programs.
Review these resources to learn more about turning compliance into a competitive edge:
- Can Compliance Help Marketing and Business Development from the Journal of Commercial Biotechnology
- SMB Validation: Four Ways to Do More With Less from the Journal of Validation Technology
- Positive Enforcement from Regulatory Affairs Focus