$ 275-375 per hour
Darshan J Kulkarni
About Darshan
Biography
Dr. Kulkarni focusses on life science companies and their service providers. He works primarily with companies small to mid-sized pharma companies, Clinical Research Organizations, advertising agencies that focus on the life sciences, medical device companies, and biologics manufacturers. He has helped with a variety of clinical and regulatory needs including responding to the FDA, buying and selling pharmacies, FDA submissions and the like.
If you are you trying to get your FDA regulated product to market quickly - and keep it there? Concerned that you may not be able to achieve those goals? Need help?! Reach out now.
Practice Areas
Fees and Rates
Cost
Hourly Rates
Payment Methods
- Cash
- Check
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Chat withLicenses
Licensed in New Jersey for 20 years
State: New Jersey
Acquired: 2005
No misconduct found
Licensed in Pennsylvania for 20 years
State: Pennsylvania
Acquired: 2005
No misconduct found
Location
The Kulkarni Law Firm
2929 Arch Street, Suite 1700, Philadelphia, PA, 19104
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Darshan J Kulkarni's Reviews
Avvo Review Score
2 Client Reviews
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Practice Areas
What Clients Mention
Showing 1 - 2 of 2 reviews
Posted by anonymous | November 21, 2016 | Hired Attorney
Pharmacist Lawyer
Darshan provides a unique perspective in that he is a both Pharmacist and healthcare provider first, and a lawyer second. He understands what I value, which allows us to significantly expedite our communication.
Posted by Leonardo Cordero | November 21, 2016 | Hired Attorney | Business
Very knowledgeable and resourcefull
Darshan was a great resource to our company as we began our operations. Darshan was invaluable and worked with us as part of the team. Darshan wrote all of our contracts and will continue to do so as we conduct our business.
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Experience
Honors
2015
Best Adjunct Professor, University of the Sciences
2014
Fellow of the American Bar Foundation, American Bar Association
Work Experience
2009 - Present
Visiting Professor, University of the Sciences in Philadelphia
2009 - Present
Principal Attorney, Kulkarni Law Firm
2007 - 2009
Corporate Counsel, Nostrum Pharmaceuticals
2005 - 2006
Clerk to the Hon. Clifford Scott Green, US District Court Eastern District of Pennsylvania
Associations
2015 - Present
American Bar AssociationVice Chair = Life Sciences Section
2014 - 2015
American Bar AssociationVice Chair - Fraud and Abuse Interest Group
2013 - 2014
National Bar AssociationBoard Member
Sample of Legal Cases
Purchase of a Compounding Pharmacy Pharmacy
Proposed Pharmaceutical Promotion Review
Responding to Federal Register
Assisting a client with a proposed medical marijuana facility
Identifying and optimizing a regulatory pathway to bring a biologics product to market
Responding to an FDA inspection
Negotiating clinical trial agreements
Education
2010
Thomas Jefferson University
Fellowship
2008
Temple University
MS
2005
Temple University
JD
2002
University of The Sciences In Philadelphia
Doctor
Speaking Engagements
2016
Webinar
Basics of Clinical Trials
2016
PSHP Annual Meeting
Responding to an FDA Warning Letter
Publications
2016
Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition, With 2016 Supplement
Federal Regulation of Advertising, Promotion, and Distribution Practices
2016
Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition, With 2016 Supplement
Pharmaceutical Compounding–Understanding the Blurred Line Between Manufacturing and Traditional Pharmacy Practice
2016
Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition, With 2016 Supplement
Medical Devices
2015
Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition
Federal Regulation of Advertising, Promotion, and Distribution Practices
2015
Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition
Pharmaceutical Compounding–Understanding the Blurred Line Between Manufacturing and Traditional Pharmacy Practice
2015
Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition
Medical Devices
2010
Principles and Practice of Pharmaceutical Medicine, 3rd Edition
India's New Era in Pharmaceuticals
Languages
English
Hindi
Marathi