NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Timothy A. Ulatowski

Practice Area Focus

  • Medical Devices
  • Development Strategy
  • Regulatory Strategy
  • FDA Compliance
  • Pre-market Evaluation
  • FDA Submissions
  • Quality Systems
  • Risk Management

Biography

Tim Ulatowski joined NDA Partners as a Premier Expert consultant in 2014. During his 36 year career with the FDA, Mr. Ulatowski was Director, Office of Compliance and Senior Advisor for Enforcement, FDA Center for Devices and Radiological Health (CDRH); Director, Division of Dental, Anesthesiology, General Hospital, and Infection Control Devices (CDRH); and Director of the Investigational Device Staff where he provided IDE application review and protocol advice. He was the FDA lead on numerous international standards committees including lead author of international guidance documents on aspects of the Global Harmonization Task Force medical device regulatory model used internationally as the basis for regulatory programs, and served as primary reviewer on numerous 510(k)s, IDEs and PMAs.

Mr. Ulatowski has more than 36 years of significant public health achievements, creating major regulatory programs and policies, developing and implementing strategic and risk management plans, and building collaborations with global regulatory partners and industry. He has proven skills in advising industry on regulatory issues, mitigating compliance and enforcement matters, creating or evaluating premarket documents, and instructing diverse audiences on regulatory and compliance topics, and was the leader of the team that developed the current FDA device standards program and author of many key FDA premarket guidance documents.