Kulkarni Law Firm

Kulkarni Law Firm Legal and regulatory compliance for life science companies and their service providers including CROs, sites , consulting companies , and agencies.

The Kulkarni Law Firm has extensive experience in pharmaceuticals, biopharmaceuticals, and medical devices The Kulkarni Law Firm is focused on the needs of FDA compliant companies. We use our experience not only in pharmaceutical law, but also in clinical trials, regulatory affairs, quality systems, and pharmaceutical manufacturing to meet clients' needs. We work with a variety of clients across f

our continents. We also stay abreast of the latest news from organizations including HHS, OIG, PhRMA, FTC, and GPHA to provide a broader perspective on their decisions.

On deck tomorrow at the Clinical Trials Agreement Summit. Let’s talk CTAs, MSAs and consequences.https://buff.ly/G6kyVIK...
08/24/2026

On deck tomorrow at the Clinical Trials Agreement Summit. Let’s talk CTAs, MSAs and consequences.

https://buff.ly/G6kyVIK

Clinical trial agreements are the backbone of every relationship between sponsors, CROs, and the research institution. Some of the biggest challenges when handling these agreements are budget negotiation, communication transparency, language determination, and technological advancements. Are you pre...

Find out why 95% of small sites are operating illegally. Looking forward to DGE and clinical trial agreement discussions...
08/21/2026

Find out why 95% of small sites are operating illegally. Looking forward to DGE and clinical trial agreement discussions on home turf. These conversations matter more than people admit.

https://buff.ly/G6kyVIK

Clinical trial agreements are the backbone of every relationship between sponsors, CROs, and the research institution. Some of the biggest challenges when handling these agreements are budget negotiation, communication transparency, language determination, and technological advancements. Are you pre...

If your trial agreements assume perfect behavior, they are lying to you. I would argue that 90% of small sites are opera...
08/14/2026

If your trial agreements assume perfect behavior, they are lying to you. I would argue that 90% of small sites are operating illegally as speak. We’ll talk about that in Philly.

https://buff.ly/G6kyVIK

Clinical trial agreements are the backbone of every relationship between sponsors, CROs, and the research institution. Some of the biggest challenges when handling these agreements are budget negotiation, communication transparency, language determination, and technological advancements. Are you pre...

Is it legal malpractice not to use AI in your practice? This week, we unpack two groundbreaking court rulings that compl...
07/16/2026

Is it legal malpractice not to use AI in your practice?

This week, we unpack two groundbreaking court rulings that completely redefine how attorney-client privilege and work-product doctrine apply to AI tools.

Click the link below to listen to the full podcast and stay ahead of the changing legal landscape.

https://bit.ly/4vUWVUC

A Pharma Lawyer Explains the AI Legal Crisis Nobody Is Talking Abou...

Your confidential data might be training AI right now without your permission. In this episode, we break down how a sing...
07/15/2026

Your confidential data might be training AI right now without your permission.

In this episode, we break down how a single AI prompt can accidentally destroy attorney-client privilege and cost pharmaceutical companies billions in patent protection.

Click the link below to listen to the full episode and learn how to safeguard your proprietary information.

https://bit.ly/4vUWVUC

A Pharma Lawyer Explains the AI Legal Crisis Nobody Is Talking Abou...

07/11/2026

Is your site using data brokers to find study subjects? Turns out doing it wrong can cost you $50,000 per subject!! As they say, conditions apply:
https://bit.ly/4w5IyNp

An Act concerning personal data, data brokers, data collectors, and amending P.L.2023, c.266 and supplementing Title 56 of the Revised Statutes.

What starts as a positive effort toward diversity in patient outreach can quickly turn into a multi-million dollar legal...
07/10/2026

What starts as a positive effort toward diversity in patient outreach can quickly turn into a multi-million dollar legal liability if data privacy isn’t tightly managed.

The article breaks down the overlapping compliance landmines facing pharma and medical device companies under modern privacy regimes.

Click through to read the full article and secure your data protocols.

https://buff.ly/aiST01Z

A positive effort toward diversity in patient outreach can quickly turn into a multi-million dollar legal liability if d...
07/09/2026

A positive effort toward diversity in patient outreach can quickly turn into a multi-million dollar legal liability if data privacy isn’t tightly managed.

Click through to read the full article and secure your data protocols.

https://buff.ly/aiST01Z

Without robust governance strategies for gender identity data, companies risk privacy law penalties, litigation exposure, and reputational fallout.

Looking forward to speaking on the 24th for the PanAgora Clinical Trial Innovation Summit in Basel. If you’re here, let’...
06/22/2026

Looking forward to speaking on the 24th for the PanAgora Clinical Trial Innovation Summit in Basel. If you’re here, let’s talk clinical trial challenges that most people ignore until it’s too late.

https://buff.ly/11EVp3p

Hosted by Roche and PanAgora Pharma, the Clinical Trial Innovation Summit looks at how pharma is improving clnical operation efficiencies to elevate the patient experience.

Trials are changing fast with digital health tools, decentralized designs, and a sharper focus on patient experience. At...
06/16/2026

Trials are changing fast with digital health tools, decentralized designs, and a sharper focus on patient experience.

At PanAgora’s Clinical Trial Innovation Summit later this month, leaders from industry and academia will share real examples of what works and what doesn’t.

I’ll be on a panel discussing the practical risks and opportunities that teams overlook until it’s too late. Come say hi!!

https://buff.ly/11EVp3p

Hosted by Roche and PanAgora Pharma, the Clinical Trial Innovation Summit looks at how pharma is improving clnical operation efficiencies to elevate the patient experience.

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100 South Juniper Street, 3rd Floor, Pa 19107
Philadelphia, PA
19104

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