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.