Regulatory Consultants
 
  1. ‣    Regulatory Services
  2. •Developing and implementing regulatory strategies for medical devices and pharmaceuticals
  3. •Determining regulatory requirements for new or modified products
  4. •Due diligence activities for startup firms
  5. ‣    Preparing Regulatory Documents and Interacting with FDA
  6. •Application preparation including IDE (Investigational Device Exemptions), 510(k)s (Premarket Notification Applications), PMAs (Premarket Approval), Device reclassification petitions
  7. •Establishment Registration and Device Listing
  8. •Interacting with FDA on behalf of sponsors
  9. ‣   Scientific Writing
  10. •Analysis of scientific and medical literature and production of summary documents
  11. •Scientific writing of documentation for pharmaceutical agents
  12. ‣   US Agent Services
  13. •Required for all non-U.S. establishments
  14. •Assist the sponsor in communicating with FDA and vice-versa
  15. ‣    Quality System Development
  16. •Development of Quality System Regulations (QSRs) for small startup medical device firms
  17. •Assessment and Audit of company QSRs
  18. ‣    Clinical Trial Design and Management
  19. •Protocol, CRF (case report form), informed consent development
  20. •IRB (Investigational Review Board) interactions
Scientific and regulatory support to medical device and health science firms
Expertise News & Links Publications Services