Regulatory: Thinking that is Unsurpassed in the Medical Device Industry

Health Policy Associates Inc. provides solutions to regulatory challenges confronting the industry today, whether those challenges arise from FDA or other worldwide regulatory authorities. HPA Inc. seeks solutions that work for companies by constructively working with regulatory authorities; we efficiently find solutions for what are often times vexing problems.

Health Policy Associates Inc. provides a full array of services including:

  • Development of FDA regulatory strategies possessing a clear path to success along with the establishment of an efficient product development project plan defining how that strategy will be successfully implemented.
  • Management of regulatory interactions with FDA including FDA pre-IDE submissions/meetings, PMA submissions and Advisory Panel presentations, and interactions with other regulatory authorities. HPA inc. is highly experienced in 510(k) submissions, PMAs, IDEs, annual reports and other required filings.
  • Development of regulatory strategies with Notified Bodies and Competent Authorities worldwide along with project plans that ensure the successful CE Marking of a company’s products.

Health Policy Associates Inc. is highly experienced in developing programs ensuring compliance with regulatory requirements worldwide.