Jeff Priem & Associates, LLC - - Quality & Compliance Consulting -
About Us
Jeff Priem & Associates, LLC is a Quality and Compliance consulting firm serving the worldwide healthcare-regulated industries.
We provide Consultant subject matter expertise and guidance to the biotechnology, pharmaceutical, and medical device  industries on GxP compliance, product development, technology transfer, Information Technology, and regulatory / CMC readiness issues and activities.

Consulting Services
  • Loaned Executive & Consultant Head-of-Quality Roles
  • Compliance & Pre-Approval Readiness Inspection (PAI) Readiness
  • Technology Transfer Strategy & QbD
  • Compliance Management System Development & Assessment
  • Quality Program Design, Implementation, Performance Management: Lean QMS 
  • Risk Management Program Design, Implementation, Training, Facilitation
  • Process & IT Validation 
  • Strategy, Implementation & Assessment
  • Software Development Lifecycle (SDLC) Program optimization
  • Cloud Enterprise Systems
Headquarter Location:
Boston, MA  USA
Management Team & Consultants
Jeff Priem is the Owner and Principal Consultant. 

JPA is a results driven systems-organization with over 25+ years of hands-on, success driven experience in the FDA & EU-regulated healthcare industries. 

  • Working in the quality assurance, compliance, operations, consulting, and engineering capacities, our consultants possess strong regulatory, product, and process knowledge, training, and facilitation expertise. 
  • We serve as subject matter experts on FDA and EU Compliance-related issues as well as on Information Technology, Product / Process Technology Transfer, PAI Readiness, Risk Management, Process Optimization, and Quality System Implementation subjects.
Copyright © Jeff Priem & Associates, LLC, 
-- Established 2009 --