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.
- 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
- Data Integrity Assessments & Remediation
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.