Our managing director has been involved in quality by design since the 1990s when the FDA and the pharma industry were just exploring the concepts.
“Applying the aspects of quality by design you taught us has cut months off our drug development cycles. From determining critical quality attributes at an early stage to streamlining our downstream activities, I continue to see lots of benefits. You gave us an excellent structure to follow.”
– Dr. Thomas Horstmann, Senior Research Director, Boston, Massachusetts
We helped the client shave 16 months off their development timelines by implementing quality by design techniques such as rapid prototyping and information management book-shelving. They calculated an immediate savings of over $5.2M.
If you’d like similar results, we can help you speed time to market and lower costs with the incorporation of lean compliance and quality by design principles and components into your current organization and SOPs. Review the following resources:
- Elucidation: Quality by Design Lessons from the Auto Industry from BioProcess International
- A Change of Course for Pharma Manufacturing, an interview from Automation World
- Executive Guide to Understanding Quality by Design