Jeff Priem & Associates, LLC - - Quality & Compliance Consulting -



Jeff Priem & Associates, LLC (JPA) helps Biotechnology, Pharmaceutical, and Medical Device companies with their compliance and regulatory challenges. 
Where are most healthcare-regulated companies challenged?
  • Is it the Regulatory Strategy?
  • Is it the Compliance Execution?
  • Is it the Product Technology Deployment?
Or
  • Are they ready for the Pre-Approval Inspection?
  • Are they ready to receive the Regulatory Agency?
These challenges typically result in compliance-related actions:
  • Submission Delays
           IND, NDA, BLA, IDE
  • Regulatory Duress Situations 
   - Increased scrutiny
   - Warning Letter
   - FDA-483
   - Consent Decree
   - Clinical Hold
  • Failed Platforms.
We are uniquely qualified to address your Quality, Compliance, and Regulatory needs.

Copyright © Jeff Priem & Associates, LLC 
-- Established 2009 --