Welcome to
Jeff Priem & Associates

Welcome to Jeff Priem & Associates, LLC, a Quality and Compliance consulting firm aimed at helping healthcare regulated companies and personnel understand world-wide regulatory compliance requirements applicable for their stage of clinical development.

Navigating the dynamic landscapes of FDA, EU, and Rest-of-World compliance requirements can be challenging at best, and overwhelming at worst. Our mission is to aid companies in advancing their clinical product programs through the various stages of clinical development as well as help facilitate and mitigate their regulatory compliance challenges to ensure ultimate success, swiftly and efficiently.

Jeff Priem and Associates, LLC has been providing these services for over 25 years in helping clients get their products to market and mitigating regulatory duress situations. Our expert consultants possess in-depth knowledge of FDA, EU, and ROW regulations and can satisfy your Quality and Compliance needs.

GXP QUALITY SYSTEMS


GXP is a complex and diverse collection of best practices for the healthcare-regulated industries encompassing GMPs, GCPs, GLPs, GDPs and GVPs to name a few. Jeff Priem and Associates, LLC helps your company meet these requirements, ensuring that your company’s processes, quality systems and infrastructure are operational, compliant, and sustainable to regulatory requirements.

GMP COMPLIANCE


Failure to comply to Good Manufacturing Practices, often resulting from a lack of knowledge or resources in clinical development product manufacture, can delay progress and compromise the clinical development product programs. Jeff Priem and Associates, LLC are experts on these detailed and ever-changing requirements and help ensure your product programs conform to applicable regulatory requirements.

GCP / GLP COMPLIANCE


Companies are tasked with establishing their Clinical Development programs and with ensuring their clinical quality and compliance operations function operate and conform to the regulatory requirements as programs from the laboratory, through the clinic, and investigator sites. Jeff Priem and Associates, LLC provides that consultant expertise to ensure the GCP/GLP compliance requirements are achieved.

REGULATORY INSPECTION READINESS


Companies ranging from small start-ups biotech’s to commercial, large commercial pharmaceutical companies face challenges with ensuring their clinical program success during regulatory inspections and meeting the applicable compliance and regulatory requirements. Jeff Priem and Associates, LLC provides inspection preparation and readiness expertise to ensure the compliance requirements are achieved.
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