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

Jane Keathley

Practice Area Focus

  • Drugs
  • Medical Device Software
  • Medical Writing
  • Project Management
  • Regulatory Affairs
  • Regulatory Submissions
  • Quality Management Systems

Biography

Ms. Keathley joined NDA Partners as a Senior Regulatory Consultant in 2013. She is an experienced medical writer and regulatory project manager, managing clinical trials and regulatory submission project teams, and she has led the implementation of compliant quality management systems in multiple health-related industries.

She was formerly the Director of Quality at Medical Automation Systems (an Alere Company), and served as the Proposal Director, Director of Quality and Process Management, and Senior Product Manager of Regulatory and Document Management at PRA International.

Ms. Keathley is a member of several professional associations including the Project Management Institute, Regulatory Affairs Professional Society (RAPS), American Medical Writers Association, and is a Senior Member of the American Society for Quality.