Background

Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. As an FDA attorney and product development consultant, he focuses on strategic regulatory and pharmaceutical counseling and has extensive experience handling the needs of international pharmaceutical, biopharmaceutical, and medical device companies and their service providers.

As corporate counsel for an international pharmaceutical holding company, Dr. Kulkarni provided corporate and regulatory legal advice. He has experience in corporate quality control and regularly performs varying legal and regulatory functions, including crafting responses to FDA titled and untited letters, reviewing potential ads, and negotiating with and for advertising agencies and scientific writing agencies.

Regulatory Compliance for Life Sciences

We help you avoid FDA compliance issues, so you don’t have to worry about legal action being brought against you.

The Kulkarni Law Firm uses its extensive experience handling complex regulatory affairs for pharmaceuticals, biopharmaceuticals, and medical devices to provide solutions to pharmaceutical companies and their service providers. Our Principal Attorney understands your concerns and can identify compliance risks and work with your organization to develop proactive strategies to mitigate these risks. By working with us as your FDA attorney and regulatory consultant, you earn change management skills and the education to develop the right global regulatory strategies for you.

  • We provide regulatory, clinical, cGMP, advertising, and general compliance-based business, legal, and strategic solutions to life sciences companies and service providers subject to the jurisdiction of the FDA.
  • We use our experience in food and drug law, clinical trials, regulatory affairs, quality systems, and pharmaceutical manufacturing to help companies with their needs.
  • We partner with a variety of clients across four continents, lending strategic intelligence services for the entire product development process, from preclinical regulations to postmarketing compliance.
  • We stay abreast of the latest news from organizations including HHS, OIG, PhRMA, FTC, and GPHA to provide a broader perspective on their decisions.
  • With extensive experience as an FDA attorney, we are proficient in working with the pharmaceutical industry’s  laws and guidances, such as the recent FDA Mobile Guidance, the False Claims Act, the Unsolicited Off-Label Guidance, the Anti-Kickback Law, the Foreign Corrupt Practices Act, the Physician Payment Sunshine Act, and HIPAA/HITECH.
Areas of Expertise

As corporate counsel for an international pharmaceutical holding company, Dr. Kulkarni provided corporate and regulatory legal advice. He has experience in corporate quality control and regularly performs varying legal and regulatory functions, including crafting responses to FDA 483s, FDA recalls, and negotiating with and for CROs and sponsors.

Dr. Kulkarni has worked as a pharmacist for more than 10 years in multiple capacities, including hospitals, retail pharmacies, managed care, and has even participated as a clinician in clinical trials.

He is Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- Regulatory Considerations.

Bar and Court Admissions
  • Pennsylvania Bar, Member
  • New Jersey Bar, Member
  • Eastern District of Pennsylvania, Law Clerk
Education
  • Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia: Doctor of Pharmacy
  • Temple University School of Law: Juris Doctor
  • Temple University School of Pharmacy: Master of Science in Quality Assurance/Regulatory Affairs
  • Temple University School of Pharmacy: Certificate in Clinical Trial Management
  • Fellowship in Interprofessional Geriatric Care
Professional Activities
  • Co-Host, Gavel & Pestle Podcast (link)
  • FDAnews, Clinical Trials Advisor Editorial Board
  • Benjamin Franklin Inn of Court, Board Member
  • University of Florida, College of Pharmacy, Professor – 2011

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None of these materials are offered, nor should be construed, as legal advice. Communication of information by or through this website and your receipt or use of such information is not intended to create an attorney-client relationship with the Kulkarni Law Firm, P.C. or any of the Firm's attorneys. The creation of the attorney-client relationship would require direct, personal contact between you and the Firm through one or more attorneys and would also require an explicit agreement by the Firm that confirms that an attorney-client relationship is established and the terms of that relationship. You should not act or rely on information contained in these materials without specifically seeking professional legal advice.