Solution-backed approaches to FDA regulations
From the mind that has decoded regulatory laws for the ABA guidebook
What We Do
We focus on providing comprehensive solutions to life science companies seeking legal, regulatory and compliance services that are consistent with the laws established by the FDA and other overseeing bodies.
Medical Affairs
We can easily place ourselves in the shoes of healthcare providers and the challenges they face in receiving accurate clinical information and real-world outcomes in order to make sound medical decisions for their patients. We step into this emerging field with compliance-focused solutions and legal advice backed by a sound understanding of clinical practices and subject matter expertise for you to offer the best to your clients.
Clinical Trials
We have created global transparency programs for global pharmaceutical companies using a customized process addressing at least 6 different types of transparencies. Through personalized interventions, we help sponsors make informed decisions on disclosure and transparency.
Promotional Compliance
The Kulkarni Law Firm helps confirm that external-facing promotional pieces released by life sciences companies are FDA compliant – based on existing laws, regulations, MAPPs, guidance, titled and untitled letters. As these laws are constantly updating with the emergence of new technologies and marketing avenues, adhering to these requirements can become challenging. This exemplifies the need for a trusted partner to navigate these legal terrains.
How we do it
A service request initiated by a client undergoes a series of considerations,
Process and Program Development
Beginning with a thorough understanding of the client’s requirements followed by a GAP analysis where the requirements are weighed against the standard of care in the industry.
Setup
An initial draft of the proposed program is developed. When determined necessary, the Firm also interviews internal and external stakeholders.
Negotiations
Establishing a set-up phase calls for negotiations with the appropriate internal and external stakeholders in order to create a program that involves all the relevant groups.
Development and Compliance
The firm ensures that your program remains consistent, and undergoes continuous process improvement. As part of this process, we conduct a consistent process of audits, and updates to address any perceived gaps.
What Our Clients Say
Darshan is constantly staying abreast of the regulatory requirements and trends/changes in clinical research. He is a fantastic source of information and a dynamic and insightful speaker. We have had the pleasure of engaging him for two keynote talks at our Clinical Research Symposium and feedback from both was that he was the highlight of the day! I appreciate his interactive approach and humor (for what can sometimes be very dry material). He keeps it light and fun, while encouraging independent thinking and challenging conversation. Above all, he is kind and intelligent and dedicated to the mission of bringing research from bench to bedside and I'm incredibly grateful for his partnership. Highest of recommendations! "
"Undoubtedly one of the best in class go-to resources for complex regulatory issues in Pharma, is Darshan. As in-house Counsel, very grateful for Darshan’s wealth of knowledge just a call away. Not to mention his level of responsiveness - bar none."
"Darshan is our go-to expert when it comes to regulatory issues and legal questions within the pharmaceutical industry. His varied background and up-to-date knowledge have been invaluable to our teams and clients. He helps us all navigate this complex and evolving space and while staying within compliance."
"I have been working with Darshan for a number of years now, being one of his first customers when he moved into his own practice. Besides being knowledgeable in the regulated clinical research arena, he has always been flexible to our company-specific needs, accountable and very responsive. I would highly recommend him if you are seeking assistance in the field of law as it applies to US-regulated clinical research."
Podcast
Listen in to Our Principal Attorney as he discusses healthcare, innovation and more on his weekly podcasts at DarshanTalks
Get in touch with us
We would love to hear about your requirement and help you get stared.
- 1645 Woodland Road, Rydal, PA 19046
- darshan[at]kulkarnilawfirm.com
- 302-252-6959