The Kulkarni Law Firm offers clinical and compliance review that can help you manage communications with healthcare providers. We can:

  • Help maintain your online presence;
  • Review proposed promotional and non-promotional documentation, video, audio or interactive media as your personal MLR/PRC Committee;
  • Ensure you remain compliant with FDA guidances and laws, such as the various declared social media guidances, and the potential off-label guidances;
  • Help avoid DOJ concerns False Claims Act, Anti-Kickback Law, and the Sunshine Act;
  • Help avoid exposure to Corporate Integrity Agreements (CIAs) and other forms of redressal, including administrative, civil, and criminal penalties.

Contact us now to bring your promotional piece to market – faster, profitably and by avoiding the FDA’s anger.

Disclaimer: The material on our website has been prepared and published for informational purposes only. There is no effort or intention to solicit new clients or new engagements from existing clients by way of this website, nor should any of the information published on the website be construed as representing any of our lawyers' availability to practice in jurisdictions where they are not authorized to do so.

None of these materials are offered, nor should be construed, as legal advice. Communication of information by or through this website and your receipt or use of such information is not intended to create an attorney-client relationship with the Kulkarni Law Firm, P.C. or any of the Firm's attorneys. The creation of the attorney-client relationship would require direct, personal contact between you and the Firm through one or more attorneys and would also require an explicit agreement by the Firm that confirms that an attorney-client relationship is established and the terms of that relationship. You should not act or rely on information contained in these materials without specifically seeking professional legal advice.