Good Manufacturing Practices aren't just regulatory requirements—they're the foundation of patient safety and product quality. Our GMP auditors bring decades of experience from both sides of the inspection table, understanding not just what regulations require, but how to implement practical solutions that work on the manufacturing floor. Whether you're preparing for an FDA inspection, qualifying new suppliers, or simply ensuring ongoing compliance, our audit teams deliver insights that transform compliance challenges into operational advantages.
What sets our GMP audits apart is the depth of understanding our auditors bring to every engagement. Many have spent years as FDA investigators, learning firsthand what catches regulatory attention. Others have built and managed quality systems for leading pharmaceutical and device companies. This dual perspective means our audits don't just identify gaps—they provide actionable roadmaps for sustainable compliance that align with your business objectives.
From small molecule pharmaceuticals to complex biologics, from Class II devices to combination products, our auditors have seen it all. They understand the unique challenges of different manufacturing environments and tailor their approach accordingly. A sterile injectable facility faces different risks than an oral solid dose operation, and our audits reflect these nuances. The result? Findings and recommendations that are relevant, practical, and immediately actionable.
Our quality professionals bring direct experience in pharmaceutical, biotechnology, combination, and medical device development and manufacturing to help you understand and address quality assurance needs at every stage of product development.
We take the lead in planning, executing, and analyzing comprehensive audits to uncover potential deficiencies and make the necessary improvements, all while empowering your staff to maintain compliance well into the future.
Our GMP Drug Audits focus on pharmaceutical manufacturing facilities, ensuring compliance with FDA regulations for drug products. We evaluate of compliance with 21 CFR Parts 210 and 211, assess of quality management systems, review production and process controls, examine laboratory controls and records, and evaluate of packaging and labeling operations.
Specific areas of focus include, but are not limited to:
Our GMP Device Audits are tailored to medical device manufacturers, ensuring compliance with FDA regulations and international standards. We evaluate compliance with 21 CFR Part 820 (Quality System Regulation), assess design controls and risk management, review production and process controls, examine CAPA systems, evaluate supplier management processes, and more.
Specific areas of focus include, but are not limited to:
Our GMP Biologics Audits focus on the unique challenges of biological product manufacturing, ensuring compliance with FDA regulations and international standards. We assess compliance with 21 CFR Parts 600-680, evaluate cell culture and fermentation processes, review purification and formulation procedures, examine viral clearance and biosafety measures, evaluate stability testing programs, and more.
Specific areas of focus include, but are not limited to:
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.