Regulatory Crisis Management

ENFORCEMENT RESPONSES & IMPLEMENTATION

If your organization has been hit with a FDA Form 483, warning letter, or Board of Pharmacy accusation or plan of correction mandate, you don’t have much time to respond and correct the deficiencies. What you need is a team of experts that have seen it all and can help you respond quickly to a regulator with cost-effective solutions that adequately address the problems. Restore Health Consulting can support you through this difficult time so you can put this in the past quickly and get on with making quality compounded preparations.

ADVERSE DRUG EVENT REPORTING & RECALL SUPPORT

Additionally, our consultants have extensive experience in handling and reporting adverse events and recalls quickly. We excel at writing the reports and press releases in such a way that defends your commitment to safe quality compounding practices, thereby mitigating unnecessary regulatory backlash. Your report or broadcast must be submitted quickly, don’t wait too long to contact the right team to get you through this situation.

EXPERT WITNESS & PROBATION MONITORING

Restore Health Consulting also provides litigation support services in matters of 503A pharmacy and 503B outsourcing facility compounding laws and regulations. We provide expert witness depositions, testimony, evidence review and detailed reports for all things compounding and pharmacy law. We also provide pharmacy probation monitoring services and assess compliance with probation agreements at the required frequency. If your compounding operation has been hit with legal issues, our expert witnesses and probationary consultants can help.