Investigations and Inquiries

Our lawyers understand the investigative process because they themselves prosecuted and defended cases. Our team has handled a variety of civil pharmaceutical and device-related investigations and inquiries. From fraud and abuse matters to private, internal compliance issues, our approach is uniquely tailored to each client and each set of facts. Whether the case requires a delicate, cooperative interaction with regulators or an aggressive stance with a government agency, our team is prepared to vigorously represent our clients' interests.

Areas of counsel include:

  • Responses to FDA's Office of Prescription Drug Promotion (OPDP) Warning Letters
  • Responses to FDA OPDP Untitled Letters
  • Responses to FDA OPDP Letters of Inquiry
  • Responses and the Defense of an Office of Inspector General (OIG)/Department of Justice (DOJ) Administrative, Civil and/or Criminal Subpoena
  • Internal Compliance Investigations
  • Whistleblower Protection
  • Investigative Document Culls and Reviews
  • Privilege Document Reviews and Consultation
  • Government Pricing Compliance Inquiries and Internal/External Investigations