Solution-backed approaches to FDA regulations

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Providing comprehensive solutions to life science companies.

Medical Affairs

We can easily place ourselves in the shoes of healthcare providers and the challenges they face in receiving accurate clinical information and real-world outcomes in order to make sound medical decisions for their patients. We step into this emerging field with compliance-focused solutions and legal advice backed by a sound understanding of clinical practices and subject matter expertise for you to offer the best to your clients.

Clinical Trials

We have created global transparency programs for global pharmaceutical companies using a customized process addressing at least 6 different types of transparencies. Through personalized interventions, we help sponsors make informed decisions on disclosure and transparency. 

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.

About Darshan

Dr. Kulkarni is the Principal Attorney of the Kulkarni Law Firm and focuses his practice on helping FDA regulated companies successfully bring their products to market. He has over 20 years of experience in providing legal, medical and regulatory services, and has served as a pharmacist for over a decade—making him uniquely well-positioned to help clients through all stages of the development process. He advises clients on issues varying from FDA regulatory strategy, clinical trial negotiations, manufacturing audits, FDA compliant promotional and non-promotional review, FDA responses, to genericization and other interdependent processes.

Prior to starting the Kulkarni Law Firm, Darshan was the Global Corporate Counsel for an international pharmaceutical holding company, where he provided services including writing licensing and employee contractor agreements, warning letters and SOPs. He was also responsible for developing a quality system for the facility and engaging with the FDA.

In his spare time, Darshan regularly contributes to his pharmacy podcast Gavel & Pestle, and has written for several books on federal regulatory law including multiple editions of Research Compliance Professional’s Handbook.

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