Kulkarni Law Firm, P.C.

From concussions to Alzheimer’s, stem cell therapy may be showing promising results. But regulations make it a legal gray area. Darshan Kulkarni sits down with Mohamed Hakim to explore how researchers are pushing forward despite the red tape. #medicalbreakthrough #healthcareinnovation #FDAregulations #kulkarnilawfirm #klf

Life science companies face heightened risks under the Trump administration: accelerated FDA approvals, increased DOJ enforcement on trial fraud, and Office of Civil Rights’ tightening of privacy standards. With research cuts and “America First” mandates, due diligence is more critical than ever. Stay ahead of regulatory shifts and mitigate risk. Partner with the Kulkarni Law Firm, P.C. for guidance in navigating these complexities. #LifeSciences #DueDiligence #DOJ #FDA #ClinicalTrials #Compliance #PharmaLaw #KulkarniLawFirm #klf

Tariffs can impact your M&A deal! Before signing, ensure vendors and customers don’t expose you to compliance risks.??? #mergersandacquisitions #pharmamergers #tariffsimpact #kulkarnilawfirm #klf

Clinical trial contracts cover legal terms, but do they address quality management? Edye Edens and Helen Maurer explore why embedding quality expectations, adaptable plans, and aligned budgets is crucial for compliance and trial success. Check out their conversation for insights!???? #clinicaltrials #regulatorycompliance #kulkarnilawfirm #klf

Are you merging clinical trial sites? Without due diligence, you risk compliance failures and litigation. Learn the 5 key areas you must review—before it’s too late.

The Site Council Preconference explored the biggest trends plaguing clinical trials today. Six standout discussions covered regulatory shifts, investigator roles, and trial innovations. Darshan Kulkarni shares the must-know insights from the event. #researchsites #clinicaltrials #industrytrends #kulkarnilawfirm #klf

Could Trump’s tariffs reshape pharmaceutical M&A? With a potential 25% tariff on Chinese pharmaceutical APIs and Canada considering its own trade restrictions, the cost of goods and sales is rising fast. Companies looking to acquire globally must rethink their supply chains, vendor agreements, and sourcing strategies to avoid unexpected costs and regulatory hurdles. Click below for Darshan Kulkarni’s take on how to navigate these changes.??? ?#mergersandacquisitions #pharmaregulations #pharmamergers #kulkarnilawfirm #klf

Would you hand over your clinical trial data if the government came asking? Researchers must navigate complex privacy laws while ensuring compliance. Edye Edens and Helen Maurer discuss what you need to know!?Click below. ???? #clinicaltrials #dataprivacy #regulatorycompliance #kulkarnilawfirm #klf??

New off-label promotion rules are shaking up the pharma industry. Regulations that once seemed stable are being challenged, and enforcement priorities are changing. With more emphasis on statutory law and the role of AI in compliance, pharma companies must be proactive in adjusting their strategies. Stephanie Trunk and Darshan Kulkarni discuss how these shifts affect pharma marketing, medical affairs, and compliance teams, and what companies should do to mitigate risk. Click below. #pharmamarketing #drugpolicy #pharmainnovation #kulkarnilawfirm #klf

Influencer says that Pharma Ads don't Inform? With all the flashy drug commercials, it’s easy to assume they’re educational. But are they genuinely helping, or just adding to the noise? Let’s explore the truth. #pharmaadvertising #pharmatransparency #darshantalks #dt