Quality Systems Consulting Services

A robust quality system is integral to ongoing regulatory compliance, smooth inspections, and audits.

Trusted in High-Risk FDA Integrity Cases

Chosen for nearly two dozen FDA data-integrity audits.

Audit-Grade Clinical Operations

Built for inspections, not just enrollment.

30+ Years in Complex Devices & Biotech

Decades guiding high‑stakes medtech and biotech programs.

Quality Systems / Compliance Consulting Services

Health Policy Associates is fully equipped to serve as an outsourced quality department, creating and implementing a customized quality system for our clients. We can also serve simply as experienced consultants and advisors on quality systems.

Our extensive experience in quality systems includes:

Quality Management System Development and Implementation, where we identify necessary procedures based on client- and product-specific needs and develop and deploy customized standard operating procedures (SOPs)
Quality System Training, where we match training to each client’s need for integration of quality-related practices into their organization
Design Control, where we offer design control solutions from concept through design transfer. Our consultants and associates guide our clients through each phase of the process and establish and maintain design history files (DHF)
Design Verification and Validation, where we determine test requirements, select and manage appropriate laboratory service providers, generate protocols and reports, analyze data, and resolve failures
Document Control, where we develop organized and functional document control and record management systems for effective and traceable implementation of quality systems
Corrective and Preventive Action (CAPA), where we create state of the art CAPA systems and assistance with implementation of effective CAPA programs, as these violations are the most common deficiency cited in FDA 483 observations
Process Validation, where we offer validation procedures and templates and lead or assist with process validation activities
Auditing, where we perform independent quality system audits to identify potential weaknesses that can be addressed prior to inspections by regulatory authorities
Post Production Services, where we create Nonconforming Material Reports, assist with analysis of complaint handling and Medical Device Reporting, provide Management Review, and create 483 and Warning Letter responses

Clarity and Confidence for FDA‑Complex Programs

You can find plenty of partners to run site visits, collect data, or assemble slides.

HPA is different: we are a senior‑led, FDA‑focused team built to help you:

And we do it all with a stable team and predictable budget.

If you’re carrying the pressure of an FDA setback, a critical submission, or a high‑risk trial, you don’t have to navigate it alone.