Promotional
Compliance

The Kulkarni Law Firm helps confirm that external-facing promotional pieces released by life sciences companies are FDA compliant – based on existing laws, regulations, MAPPs, guidance, titled and untitled letters. As these laws are constantly updating with the emergence of new technologies and marketing avenues, adhering to these requirements can become challenging. This exemplifies the need for a trusted partner to navigate these legal terrains.

Companies often rely on internal Medical Legal Regulatory boards (often also called Promotional Review Committees or PRC Committees) to evaluate promotional pieces to ensure they comply with legal requirements including those from the FDA, HHS, DOJ, OIG and a variety of other governmental and non-governmental organizations. The Kulkarni Law Firm provides this as an outsourced service for both large and small companies. Our service allows organizations to remove their fixed overhead and at the same time offers trustworthy and reliable resources to review potential ideas and concepts. We can create a customized interdisciplinary team of experts to address concerns expressed by internal teams and provide an unbiased perspective on potential ideas which can get compromised with an internal team who are already invested in the idea.

Our MLR services allow your company and your advertising agencies and scientific writing companies to not only focus by providing quick and efficient reviews, but also allow you to bring your promotional and non-promotional pieces to market more efficiently.