Our Guarantee 

First Responder Guarantee

If necessary, we’ll be in your office within 24 hours of receiving your call!

When “stuff” hits the fan, you can count on us to be at your side IMMEDIATELY! We guarantee to be at your business location within 24 hours – ANYWHERE in the WORLD! We are your “First Responder” for all your compliance emergencies.

  • Unannounced Audit?  You can count on us to get you prepared.

  • Receive a warning letter?  Call us before you answer.

  • FDA shows up unannounced? Call us! We will support you remotely until we can arrive onsite.

  • Recalls, Field Actions, Serious Adverse Events, or another emergency?  Get EXPERT advice ASAP.


These events are stressful for you. Stay calm and relax! Easier for us to say than for you to do; however, it’s the best advise you can receive in an “emergency” situation.


We’ve encountered these situations many times in our more than three-decades of experience with compliance issues.  Call us NOW! We’ll advise you on how to proceed.

We will literally jump on a plane and be in your office within 24 hours if that’s what it takes.

To get started:

Call us now at (520) 665-9081


Do you know we have an audit service to prepare for a regulatory agency audit? If you do not

have an emergency today, but wish to prevent a future emergency tomorrow, our audit service

is for you.


We offer Mock FDA Inspections, MDSAP Readiness Assessments, and EU MDR Assessments. Click Here to learn more or call us at (520) 665-9081.


Thank you,


Melita Ball

CEO & Principal Consultant