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.

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.

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.