Lean Regulatory Affairs Fast-Tracked
For a mid-sized pharmaceutical company, we designed and put in place a flexible, cost-effective regulatory affairs framework to match a complicated business environment with global compliance requirements – all in record time:
“John Avellanet’s frequent speaking engagement requests from the industry are a reflection of his expertise and reputation. In 2009, we got to see this first hand. John helped us on a business-critical project expected to last 9 months. Midway through, senior management challenged us to expedite the project by 3 months and we succeeded thanks to John’s dedication to get the job done – and done right. He found the time to help us fast-track the project although he was in the process of writing and finishing his new book. If I had to characterize John and his firm Cerulean in 3 phrases, they’d be: expert, on-time and high integrity.”
– Anita Fauchier, Director of Regulatory Affairs, Atlanta, Georgia
Following an on-site mock FDA and PAI audit, we made a series of short- and long-term recommendations to improve compliance and boost productivity while lowering costs. We then worked with the client to revise and process map SOPs, policies, forms, and internal guidelines. The result was a savings of $400,000 is resource workload and – as an added bonus – the prevention of an FDA warning letter after agency reviewers saw the first results of our work.
- Lean Compliance for Mid-sized Companies from the Journal of GXP Compliance
- Building Compliance for Personalized Medicine from BioProcess International
- Checklist: 38-point Lean FDA Compliance Self-Assessment
If you’re worried how to revise your compliance for the 21st century, see our lean FDA quality system and regulatory affairs consulting services.