Regulatory inspections by the Food & Drug Administration, as well as regulators around the globe are increasing. For companies that are inspected, it is almost a certainty that the inspection will result in some punitive action. These actions have the ability to put companies out of business, or force unwanted mergers or acquisitions that do not provide desired shareholder compensation.

When the FDA issues an action, companies have a great deal of work to do. It is critical that companies address their communications policies and needs during this time in order to emerge from the FDA action in a position to continue doing business.

Yorke Healthcare and Regulatory Communications provides expert insight and counsel for healthcare companies faced with FDA inspections and those who’ve received Form 483s or even consent decrees. YHRC knows that proper communications is key to:

 

• Remaining compliant

• Keeping patients safe

• Encouraging a spirit of trust and cooperation with the regulatory body

• Defending the company’s reputation from competitors quick to spread rumors

• Ensuring that all key stakeholders – shareholders, physicians, patients, etc. – are kept informed with the most appropriate information at the most appropriate time

 

To do this, YHRC provides comprehensive and regulatory-focused crisis communications planning and execution. Regulatory communications services include:

• Proactive plan development

• Compliant key message development

• Compliant communications training

• Media relations

• Social media policy training

• Competitor response strategy development

• Sales force guidance

• Stakeholder communications strategy development