Jeff Priem & Associates, LLC, headquartered outside of Cambridge, MA, is a results-driven consulting firm specializing in the providing quality and compliance solutions for the healthcare-regulated industries encompassing pharmaceutical, biotech, and medical device companies moving through the various phase of clinical development: start-ups through commercial development.
With over 25 years of experience serving the healthcare-regulated industries, we are an industry leader in providing operational and sustainable solutions for our Client’s needs. Our experienced teams of Consultants serve as subject matter experts on FDA and EU Compliance-related issues as well as on Clinical Development, GXP Compliance (GMP, GCP, GLP, GDP and GVP), Information Technology, Product/Process Technology Transfer, Pre-Approval Inspection Readiness, Risk Management, Process Optimization, and Quality System Implementation subjects.
We work with our Clients to develop practical and pragmatic quality and compliance solutions to satisfy the Client’s compliance requirements. We provide strategies as well as the hands-on expertise to establish and / or remediate existing Client’s foundation quality systems to be operational, sustainable and fully compliant to the applicable regulatory requirements.
Headed by the Principal Consultant, Jeff Priem, Mr. Priem has over 25 years of experience in quality, GXP compliance, product development and risk management serving the pharmaceutical, biotechnology, and medical device industries. Working as both a consultant and as the Head of Quality in industry roles, he has helped companies to successfully address their regulatory duress situations (e.g., consent decree, warning letter, FDA-483) as well as progress their clinical development product programs through the phases of clinical trials, technology transfer, and commercialization / expansion stages to ultimately achieve successful regulatory inspections results (e.g., FDA-PAI). He is a published author and frequent industry presenter. Mr. Priem received a B.S. in Mechanical Engineering from Rutgers, The College of Engineering.