We can support and even lead your Compliance function.

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Paying HCPs, product discounting, providing reimbursement support and other promotional activities present great risk. The best way to mitigate jeopardy is through an effective compliance program.

Gardner Law can help you accomplish your commercial goals in a compliant fashion. We help clients assess and mitigate regulatory risk.

We assess commercial activities for compliance with the following laws:

  • Food, Drug and Cosmetic Act
  • Anti-Kickback Statute
  • False Claims Act
  • Physician Payments Sunshine Act
  • Stark Law
  • Foreign Corrupt Practices Act
  • Federal Trade Commission Act

Aggressive government enforcement of these laws continues. New cases are being brought every day, often by whistleblowers, against manufacturers and prescribers under off-label promotion, anti-kickback, and false claims prosecutorial theories. Failure to comply with these laws can drive a manufacturer out of business, or worse, put employees in jail.

We help clients achieve their commercial goals in a compliant fashion.

Gardner Law can help you mitigate risk by designing, implementing, and monitoring your compliance program. We provide training, auditing and daily hands-on support to manufacturers.

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Compliance Services offered by Gardner Law include:

  • Leading the Compliance Function
  • Designing and implementing compliance programs
  • Training management teams and staff on compliance laws and regulations
  • Analyzing Sales and Marketing programs for compliance with FDA, CMS, OIG requirements
  • Assisting companies subject to Corporate Integrity Agreements (CIA)
  • Investigating allegations and hotline reports
  • Reviewing discounting practices for Discount Safe Harbor compliance
  • Analyzing transfers of value to HCPs for compliance with the Personal Services and Management Contracts Safe Harbor
  • Reviewing reimbursement support services and program hubs
  • Conducting compliance audits and compliance risk assessments of commercial activities
  • Helping to mitigate, wind-down, and/or terminate risky practices
  • Performing healthcare and FDA regulatory due diligence for buyers and sellers
  • Reviewing research activities, e.g., advertising and recruitment practices
  • Training on best documentation practices
  • Reviewing contracts
  • Reviewing privacy policies
  • Auditing against the PhRMA and AdvaMed Codes

Looking for a place to start?

Utilize our compliance checklist.

Download Checklist

Learn more about information on recent changes to the AdvaMed Code.

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