The Kulkarni Law Firm assists legal, regulatory, and quality departments with the development, auditing, and training of standard operating procedures (SOPs); risk assessment and management; contract development; and assistance during litigation.

We also specialize in crisis management for life sciences companies, including responding to FDA 483s, warning letters, and titled and untitled letters, as well as other services offered by an FDA attorney, such as the negotiation of recalls.

We can also help you through an FDA inspection, assist with distribution or registration, plan a clinical trial, and much more.

Are you trying to avoid problems or need help from an FDA attorney due to unwanted assistance from the FDA or another governmental agency? If so, contact the Firm today.

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.