Crisis Prevention and Recovery Services
- Proven track record with FDA enforcement actions
- Recognized experts to prepare and defend you approach
We will work closely with your internal staff, external vendors, your FDA counsel, and FDA itself to minimize the impact and extent of FDA enforcement actions. We help you understand FDA’s underlying intent so you can develop appropriate and effective responses. If you don’t already have regulatory counsel we can help you select one.
Our approach focuses on increasing your credibility with FDA through timely and effective communication and realistic commitments. We are sensitive to your business objectives and regulatory risk management philosophy and develop pragmatic approaches for short and long term benefit. We are also sensitive to public health risks and legal issues.
We have special expertise in medical device design control, risk management, software validation as well as medical device and pharmaceutical computer system validation.
Our track record in assisting clients includes avoiding or recovering from FDA enforcement actions including: consent decrees, denying premarket clearances, stopping product shipments, resolving inspectional issues, and responding to pre-market clearance deficiency letters.
Crisis recovery requires an ability to set priorities quickly, coordinate available resources, communicate across the internal and external parties involved, and negotiate effectively. Crisis management skills come from a combination of real world experience with crises and the personal characteristics of those involved. We only assign senior partners with extensive experience and appropriate skills to coordinate crisis recovery activities. Some of the credentials of the key partners involved in our crisis recovery services are listed below:
Alan Kusinitz, SoftwareCPR® Managing Partner, provides internal training at FDA and is a trainer for public AAMI/FDA Software Validation, Design Controls, and Quality System Regulation training. Alan has been involved with a wide range of crisis recovery activities including extensive direct interaction with FDA for device and drug actions.
Brian Pate, SoftwareCPR® Partner, has also provided internal training at FDA and is an active faculty member for public AAMI/FDA Software Validation and Agile Methods courses. Brian has also taught the AAMI/FDA Design Controls course. Brian has been involved with a wide range of crisis recovery activities including for-cause inspections, warning letter responses, regulatory submission questions.
Molly Ray, SoftwareCPR® Partner, is a former FDA staff member has been involved on both sides (industry and FDA) of enforcement actions and pre-market deficiency issues.