Health Policy Associates

Westwood,  MA 
United States
http://www.healthpolicyassociates.com
  • Booth: 309

For 24 years, Health Policy Associates (HPA) has been providing practical, efficient consulting solutions to companies involved in developing new medical device technologies, pharmaceuticals, and biologics.  Health Policy Associates specializes in bringing the best regulatory, and clinically focused strategic thinking in the industry to clients throughout the world.  As a boutique consulting firm with CRO capabilities, HPA fills the gaps between the large CROs and the individual consultants.  

HPA Capabilities Include:

  • US and OUS regulatory strategy and submission support
    • 510(k) submissions
    • IDE's
    • PMA's
    • BLA's
    • Technical files / design dossiers / clinical evaluation reports for CE mark
    • Canadian license applications
    • Applications in Australia, India, China, Brazil, Japan and
      other global markets
  • Full internal team of industry-trained Quality Assurance professionals
  • Full-service CRO/Clinical Operational Services
    • Internal monitoring
    • Medical writers
    • Internal CRAs
    • State of the art EDC System
      • Internal SAS programmers
      • Data analysis
    • In-study audits of client CRO's to evaluate performance