At FDAQRC, we provide trusted compliance solutions to pharmaceutical, biotech, and medical device companies around the globe.
Across All GxP
FDAQRC has expanded our Current Good Manufacturing Practices (cGMP) by including a broad range of comprehensive quality and regulatory compliance services.
FDAQRC has a new Recuiting line of service known as FDAQRCandidates which will specialize in placing life sceince professionals in permanent, interim and contracted positions.
For Quality Jobs
FDAQRC has nearly doubled in size over the past year and we are actively looking for new members to join in multiple departments - view open positions on our Careers page.
Have a question or want to discuss an upcoming project? Send us a message today.
Your Worldwide Compliance Partner
Where Expertise Meets Excellence
At FDAQRC we partner your needs with the ideal Consultant. We have over 300 Consultants in our network to ensure we meet your technical requirements.
If you are looking to partner with us, you can use this online tool to start the registration process. If you are already registered with us and would like to review your profile, please login.
logistics in addition to our Quality Systems,
Clinical Operations and overall compliance.”
above expectations.”
comprehensive it is. This is the kind of information
and resources I love to have for every audit I perform.”
opportunity to develop a strategy to
move things forward.”
and very accommodating. They handled all of the
administrative details, which was very helpful. All interactions
were professional and collaborative.”
prompt and helpful response."
INDUSTRY INSIGHTS
Decoding Your FDA Form 483 and Warning Letter: A Practical Guide to Remediation
This article explains how to interpret an FDA Form 483 and Warning Letter, identify underlying causes, and develop an effective remediation strategy. It emphasizes the importance of timely, well-documented corrective action and provides practical guidance for addressing inspectional observations.
How to Prepare for an FDA Inspection: A Step-by-Step Guide
An FDA inspection doesn't have to be daunting. Our step-by-step guide provides a roadmap for proactive preparation, covering everything from QMS review to effective FDA-483 responses. By taking a proactive approach, you can ensure your team is ready for a successful inspection outcome.
Practical Guide on How to Adapt Your Auditing Practices for the Implementation of ICH E6 (R3)
Download this poster to explore how evolving global guidance is shaping the future of auditing, including risk-based approaches, updated SOPs, and technology-driven practices.
Understanding Quality Oversight: Monitors vs. Auditors vs. FDA: A Quality Perspective
A practical breakdown of how monitors, auditors, and FDA inspectors each contribute to quality oversight, compliance, and inspection readiness across the trial lifecycle.
A Closer Look at Inspection Readiness: Mock/Hats On-Off Approach
A practical framework for strengthening compliance, inspection behaviors, and organizational preparedness for regulatory inspections
How to Secure Project Assignments with FDAQRC: A Guide for Consultants
At FDAQRC, project assignments are thoughtfully matched to consultant expertise, availability, and readiness, so understanding what influences those decisions can help you position yourself for more opportunities.
Tips For Preparing & Hosting a Successful Audit
Turn audit stress into strategic success with these expert preparation and hosting tips
Regulating AI in Clinical Trials: What ICH E6(R3) Does (and Doesn’t) Say
Despite AI’s growing role in clinical trials, ICH E6(R3) remains silent—does this leave room for innovation or uncertainty?