Kulkarni Law Firm, PC

Contact Information

http://www.kulkarnilawfirm.com

Darshan Kulkarni

Founding Attorney

Darshan@Kulkarnilawfirm.com

Consultancy Services Offered:
Food and drug attorney, pharmacist, educator, and founder of the Kulkarni Law Firm, PC, advising nutraceutical, wellness, pharmaceutical, biotech, and health technology companies on FDA, FTC, and healthcare compliance. Experience includes clinical research, promotional review, telemedicine, medspa and wellness compliance, dietary supplement regulation, privacy, and product lifecycle strategy. Former Vice President of Regulatory Strategy and Policy and current adjunct professor at Drexel Kline School of Law.

Frequent speaker, podcast host, and author on life sciences, clinical research, and emerging wellness regulatory issues. Advises companies ranging from startups to established manufacturers, sponsors, and service providers on practical, business-focused compliance solutions involving advertising, labeling, clinical trials, digital health, and operational risk management.

Link to list of publications:
https://scholar.google.com/citations?user=jrX26GgAAAAJ&hl=en&inst=7236018610508487091

Key Words:

  • FDA

  • Research

  • Supplements

  • Wellness Regulation

  • Advertising

Types of services offered:

  • Research and Development

  • Regulatory Affairs

  • Sales

  • Marketing

  • Manufacturing

  • Quality

  • Legal

  • Public Speaking

  • Scientific Research

  • Medical Affairs

  • Labeling & Claims Compliance

Primary Industry:

Pharmaceutical

Regions Served/Regional Experience:

US

Preferred Project Format:

Remote

Location & Time Zone:

EST

Languages Spoken:

Hindi, Marathi, English

Regulatory Expertise:

FDA

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