Part 3 of Top Regulatory Tips
« Tips 3 & 4
Tips 7 & 8 »
Tip #5: Put together a complete team
It takes input from a variety of disciplines to ensure FDA's needs are met. Science and engineering are critical to product design and development. Along the way, other areas of expertise should be included such as clinical development, regulatory affairs, quality assurance, quality control, process development, marketing and sales. These disciplines may not always agree and will likely have competing requirements. But it's critical to be making business decisions with each of these voices in the mix ... otherwise it's likely you'll overlook something critical.
Tip #6: Educate and traing the entire organization on regulatory
If an organization is going to be successful in diagnostics, it's overall "Regulatory IQ" needs to be very high. Everyone in the organization from the Board of Directors to the technicians on the line need to understand the regualtory and quality environment. I like to call this concept Regulatory Sophistication. In the most successful organizations, knowledge of FDA fundamentals is simply expected.
We're in the middle of the week ... hopefully these tips will keep you going through Friday!