Darshan Kulkarni helps FDA regulated companies stay compliant. He has a Doctorate in Pharmacy, a Juris Doctor degree and a Masters in QA/RA. He services the compliance needs of FDA regulated companies including drug and device companies, pharmacies, CROs and sites, technology companies, advertising agencies, and even other law firms. He is regularly called on to advise on compliance issues related to clinical research, promotional compliance, manufacturing, pharmacy, and medical affairs. He is also often consulted during the purchase or sale of FDA regulated companies.
Dr. Kulkarni serves on multiple advisory and editorial boards. He has written chapters for several editions of multiple books and has been invited to give keynote speeches globally on various life science related topics. He has lectured nationally and is currently adjunct professor at Drexel University School of Law where he teaches food and drug law and promotional compliance.