Quality Assurance

What should you be thinking about before your regulatory submission?

In short – are you truly ready for your final regulatory submission? And if not, how are you planning to get there?

The best answer is to work with a team of Quality Assurance professionals who have been there and done that. People, for instance, who have decades of clinical development experience — covering everything from the FDA, EMA, MHRA and BfARM to DEA, ANSM — and have successfully managed 10 regulatory inspections which resulted in product approvals.

At Aperio, our Quality Assurance Services team is uniquely positioned to help you understand the big picture — and take care of all the details that can make the difference between success and failure.

We’ll tailor our engagement to support and supplement your team. We’ll show you the cumulative benefits of implementing a step-by-step inspection readiness plan. We’ll create a customized plan that’s specific to your indication and findings. And we’ll call out weak arguments and incomplete data. All to make sure that you’re more than ready when the agency arrives or at any point in the process.

Want to see what your inspection prep missed? Let’s talk.

Our Quality Assurance Services team can guide you every step of the way.

  • TMF Audit
  • Clinical Site Inspection Readiness Visits
  • BIMO or other applicable questionnaire
  • Inspection Readiness Training
  • Mock Inspection
  • Host or Co-Host Inspection
  • Management of your Inspection Readiness Room

Or we can take you through just the specific steps you need, including:

  • Site Audit
  • TMF Audit
  • Vendor Audit
  • Quality Document Creation