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.

This DGE session is designed to be practical and uncomfortable. That’s where learning usually happens.https://bit.ly/4rM...
05/21/2026

This DGE session is designed to be practical and uncomfortable. That’s where learning usually happens.

https://bit.ly/4rMt5zi

The 5th HCP Spend & Monitoring Summit provides “must have” information for enhancing operational efficiency in transparency reporting and maintaining compliance. You’ll gain practical strategies, tools, and best practices to streamline HCP spend reporting and ensure accurate, timely submission...

Excited to speak on clinical trial agreements again!! What does the future hold?
05/12/2026

Excited to speak on clinical trial agreements again!! What does the future hold?

05/11/2026

Are you a physician interested in anti-aging medicine or wellness therapies? Are you considering using peptides now or in the future? Well, if you had asked me 2 weeks ago, I would have been worried for you. But the regulatory landscape for BPC-157 just shifted.

For many compounding pharmacies and physicians, it’s no longer on the "naughty list," signaling a green light for compounding to resume.

However, as an FDA regulatory attorney, I’m seeing a dangerous trend: patients bypassing the clinic to buy "research only" vials online.

If you are a physician contemplating integrating BPC-157 into your protocols, here is what you need to know to stay on the right side of the law:

1. Physician Oversight is Mandatory: The removal of certain restrictions doesn't create a "wild west" scenario. A valid patient-provider relationship and a specific prescription are still the legal bedrock of compounding.

2. The "Research Only" Trap: Products marketed online as "not for human consumption" or "research grade" bypass FDA manufacturing standards. If a patient takes these without adequate supervision, you could face vicarious liability.

3. Documentation is Your Shield: Ensure your charts reflect a clear medical necessity for the compounded peptide over commercially available alternatives. Research without an actual plan borders, if not crosses into, malpractice. Make sure you have all your documentation in place.

If you're unsure if your sourcing or consent forms meet current FDA expectations, now is the time to audit your peptide protocols.

Have you seen an uptick in patients asking for BPC-157? Message me to discuss the shift in the comments.

DTC missteps, AI, influencers and enforcement are now sn*******ng fast, amplified by the same platforms brands rely on. ...
05/08/2026

DTC missteps, AI, influencers and enforcement are now sn*******ng fast, amplified by the same platforms brands rely on. We’ll map where risk hides and how governance can help. Come to the conference to find out

https://bit.ly/4rMt5zi

The 5th HCP Spend & Monitoring Summit provides “must have” information for enhancing operational efficiency in transparency reporting and maintaining compliance. You’ll gain practical strategies, tools, and best practices to streamline HCP spend reporting and ensure accurate, timely submission...

05/04/2026

Your blood pressure tracker might no longer be a 'medical device.' Here are 3 ideas how to pivot your marketing without triggering the FTC:

1. Dont make disease claims: Dont say that your device can "detect hypertension." Consider options like visualizing daily fluctuations.

2. Gamify "Stress Management"
Focus on holistic stress optimization. E.g Its not about the BP but about the "Stress Score" or "Zen Check,". This way, you firmly stay in the wellness space and not the medical space.

3. Target "Biohackers": High-performance crowds love data for the sake of optimization. Use language centered on longevity and performance rather than illness and treatment.

If you aren't a medical device, stop using medical language. Delete words like diagnose, treat, cure, or prevent from your copy immediately to stay off the regulatory radar.

Speaking at DGE this June on surviving the DTC crackdown. Enforcement posture shifted hard in late 2025, and many teams ...
05/01/2026

Speaking at DGE this June on surviving the DTC crackdown. Enforcement posture shifted hard in late 2025, and many teams are still pretending nothing changed. What impact will it have on influencers?

https://bit.ly/4rMt5zi

The 5th HCP Spend & Monitoring Summit provides “must have” information for enhancing operational efficiency in transparency reporting and maintaining compliance. You’ll gain practical strategies, tools, and best practices to streamline HCP spend reporting and ensure accurate, timely submission...

03/30/2026

Teaching forces you to explain things clearly. On March 31, I’ll be teaching life science entrepreneurship at the University of Delaware. I am focusing on how ideas survive contact with regulation. What should I be sure i talk about?

03/26/2026

I hate sterile courses! I’ll be teaching a class at the University of Delaware on March 31 focused on entrepreneurship in the life sciences.

We’ll talk about what it actually takes to build companies in regulated markets, not the sanitized version you see in pitch decks. If you’ve built, advised, or funded life sciences startups, you know how messy this really is.

What is a "twist" I can show them that gives them a taste for real life?

On deck tomorrow morning at PhUSE. Looking forward to a room full of people who live with these decisions daily.https://...
03/23/2026

On deck tomorrow morning at PhUSE. Looking forward to a room full of people who live with these decisions daily.

https://bit.ly/4rgyuyO

PHUSE will bring together the clinical data science community for a week of innovation, collaboration and fresh perspectives. With interactive discussions and hands-on learning, this event is all about sparking ideas and pushing boundaries.

AI is forcing a rethink of anonymization, IP rights, and plain language summaries. If your data strategy assumes old rul...
03/20/2026

AI is forcing a rethink of anonymization, IP rights, and plain language summaries. If your data strategy assumes old rules still apply, this will be uncomfortable.

https://buff.ly/R3A5M7N

PHUSE will bring together the clinical data science community for a week of innovation, collaboration and fresh perspectives. With interactive discussions and hands-on learning, this event is all about sparking ideas and pushing boundaries.

Most pharma marketers are focused on what AI can do. But AI creates risks. I was quoted in MM+M discussing the regulator...
03/17/2026

Most pharma marketers are focused on what AI can do. But AI creates risks. I was quoted in MM+M discussing the regulatory future of AI in pharma marketing.

This is a conversation every pharma marketing and legal team should be having right now.

Article here:
https://www.mmm-online.com/news/more-ai-regulations-are-coming-what-pharma-marketers-need-to-know/

As more states enact laws that regulate how AI is used in healthcare marketing, pharma marketers will need to build guardrails around transparency, bias and human-in-the-loop.

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