Services
Kulkarni Law Firm focuses on Life Sciences and FDA-regulated legal matters ranging from
clinical trials, to advertising and marketing, to drug dispensing. Our firm offers clients an
opportunity to meet directly with the Principal Attorney, who has an extensive background in
legal, medical, and regulatory services, in addition to experience working as Corporate Counsel
for an international pharmaceutical holding company. The services that we provide include
conducting corporate quality control and performing legal and regulatory functions such as
responding to FDA titled and untitled letters, looking over potential ads, and more. We know the
unique challenges facing our clients, and are well-prepared to help you deal with compliance
issues concerning FDA requirements as well as with your other legal matters.
Research

We offer assistance to sponsors, CROs and sites with aspects of their trials which fall outside of their scope of expertise.  We negotiate clinical trial research agreements, send out updated agreements, and have counseled clients in responding to FDA 483 and warning letters. Additionally, we have created risk assessments, as well as ensured GxP adherence by creating SOPs and helping with FDA inspections.  We take pride in helping companies develop transparent, patient-focused clinical trials.

Education

The Kulkarni Law Firm also handles matters relating to advertising law, and can help life science review their proposed collateral and ideas prior to sharing them with patients and healthcare providers.  We can also ensure that promotional ads meet the appropriate regulations, and look over existing SOPs and create new SOPs if necessary.  Some of our clients include companies dealing with food, dietary supplements, cosmetics, nicotine products, and medical devices.  We also offer our expertise to sales teams and medical affairs teams on compliant communications, and are committed to ensuring that proposed information meets FDA regulations.

Dispense

Our practice also covers the broad field of pharmacy law, including the review of potential buy-sell agreements, setting up compounding and investigational drug pharmacies, and helping pharmacies successfully navigate state and federal laws and regulations.  We have worked with companies to ensure that they are meeting FDA as well as pharmacy state board requirements. Additionally, we have also set up telepharmacy training programs designed to help pharmacies better reach their clients.  We know the unique challenges facing these practices, and are well-prepared to help our clients deal with compliance issues concerning FDA requirements as well as with their other legal matters.

Disclaimer: The material on our website has been prepared and published for informational purposes only. There is no effort or intention to solicit new clients or new engagements from existing clients by way of this website, nor should any of the information published on the website be construed as representing any of our lawyers' availability to practice in jurisdictions where they are not authorized to do so.

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.