At inSeption Group, we can effectively prepare your company for FDA approval and inspection. We can set up a mock inspection of your company, proactively identify any concerns, and help you mitigate the risks along the approval process. Our FDA mock inspection process in the example below is an example of the steps we take to help protect your company’s reputation and your product approval process, and we can do the same for you. (Click here to see our Mock Inspection Challenge Solution PDF for a scanning code.)
Challenge
A new, emerging biotech company was preparing to submit their NDA. Anticipating an FDA inspection, they wanted to take a proactive approach to mitigate risks and identify potential concerns.
Solution
inSeption Group crafted a risk-based strategy, blending elements of mock inspections, clinical site preparation visits/audits, and review of critical documents (e.g., TMF), processes, and training—designed to thoroughly examine all elements of the company’s clinical studies and Quality Management System.
Benefit
With this customized risk-based mock inspection, the sponsor was able to identify and address any potential gaps that could warrant more scrutiny within their application. Working with inSeption Group allowed the sponsor to be ready for every possible scenario, eliminating the stress and anxiety that often results from preparing for an FDA inspection.
“We are very, very grateful for your work and collaboration. This was an amazing achievement, and we have all of you to thank! What’s your secret? How do you do this time and time again?
“You are gladiators!”
At inSeption Group, we are a full-service global outsourcing solution for guidance through clinical trials. We provide support throughout the clinical trial life cycle, site management and clinical monitoring, as well as medical writing and quality control. Reach out to us today for your clinical trial outsourcing needs.
