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.
Major Hoffman is the lead marketing manager at Kulkarni Law Firm. In that role, Major develops and implements marketing strategies for the firm, and oversees the firm’s social media, email marketing system, and website design. He has extensive experience in all aspects of marketing development and serves as an advisor for the firm’s branding needs.
Sunil Philip serves as the principal accountant and is responsible for handling the firm’s legal transactions as well as serving the role of financial advisor. He has over 20 years of experience in the tax advisory industry.
As the firm’s bookkeeper, Matt Hepler documents all financial transactions in addition to generating comprehensive financial reports for the firm.
Sarah Vince is the customer relations associate and has an extensive background in the customer service industry. She helps build close and ongoing relationships with potential clients. She also assists with the production of content for the firm’s social media accounts.
Lawyer teams we work with:
Yash Kulkarni is a leading barrister for Quadrant Chambers and has a broad commercial practice with international reach. He regularly advises for companies in industries such as international trade, banking, information technology and insurance.
The Law Offices of Coleen F. Middleton, Esq.
As a former Assistant United States Attorney, Coleen has an extensive background in handling litigation and appeals, as well as investigations and criminal matters. She also has over 20 years of experience working as a lawyer for various global billion-dollar companies.
Raksha Jain is a well-practiced attorney based out of Mumbai, India who focuses on a wide range of legal services including energy and infrastructure, corporate and commercial documentations, estate planning, banking and finance, real estate, and intellectual property.