The Kulkarni Law Firm is focused on the needs of FDA compliant companies. The Firm uses its experiences not only in pharmaceutical law, but also clinical experiences, regulatory affairs, quality systems, and pharmaceutical manufacturing to meet the needs of its clients. It works with a variety of clients across 4 continents from 2 person startup companies to some of the largest companies in Europe and in other continents.
The Firm stays abreast of the latest news from a variety of organizations including HHS, OIG, PhRMA, FTC, and PhRMA and GPHA to provide an broader perspective on decisions made.
To see how the Firm can help you and your company, reach out to us via our website.
Specialties
FDA Negotiations, Park Doctrine, Corporate Compliance, Reg Aff, Clinical Trial Negotiations, Licensing, Clin Trial Compliance, Recalls, Int Pharma compliance, Social Media development, Pharma advertising, Life Cycle Mgmt, State registrations, SOP Development