Compliance Partner
Where Experts Meets Excellence
FDA Quality and Regulatory Consultants (FDAQRC) is a leading provider of regulatory compliance solutions for pharmaceutical, biotech, and medical device companies globally. Our expert employees and consultants are experienced across all GxP areas to best suit client needs at all phases of product life cycle and development.
FDAQRC provides a range of services such as quality audits, mock inspections, gap assessments, remediation services, recruitment, and more. Through our global consultant network, we pair our clients with experts for every project, regardless of location. FDAQRC has around 500 active consultants in every major region (70+ countries). Our consultants go through an extensive vetting process, which allows us to personalize their consulting experience as well as ensure their expertise will align effectively with the specific requirements of each project.
✓ Global Regulatory Compliance Leader
✓ Expertise Across GxP Areas
✓ Comprehensive Services
✓ Advanced Consultant Network
✓ Personalized Consulting
✓ Excellence in Regulatory Compliance
✓ Tailored Solutions
✓ Client-Centric
✓ Trusted Partner
Setting the Standard in Global Quality & Regulatory Compliance
We excel in providing comprehensive support for projects in the realm of all GxP areas. We understand that your project’s needs may evolve, and we are ready to assist you at any stage of your journey. Below is a list of main categories in which we offer services, but our capabilities do go beyond this realm.

Experts Across All GxPs
FDAQRC proudly boasts a global consultant network, demonstrating our dedication to top-tier service in quality and regulatory. With a decade of experience in 70+ countries, our powerhouse team covers all GxP areas, addressing diverse industry needs.
We take great care in selecting highly qualified individuals to join our esteemed network by following our stringent internal requirements for consultants.
˄ CONSULTANT QUICKLINKS ˄

Regulating AI in Clinical Trials: What ICH E6(R3) Does (and Doesn’t) Say

Explores the Differences Between Auditors and Inspectors in the Clinical Research Industry

Competency Based Programs Contribute to Early Clinical Research Professional’s Training

15 Years of Excellence: FDAQRC's Journey and Future Vision

Tips for a Positive Outcome While Performing a Challenging Audit

How To Find Qualified Patients for Your Clinical Trials

Simplified SOPs Can Reduce FDA Citations and Enhance Compliance Culture

Creating a Supportive Workplace: Recognizing and Addressing Mental Health

AI in Clinical Trials: Transforming Research and Regulation

FDAQRC's Retreat and Reconnect

Pharmacovigilance: Insights, Challenges, and Future Horizons

The Future Looks Bright

FDAQRC Named a 2024 Aggie 100 Honoree

Celebrating 14 Years of Excellence

Mastering the Difference: Monitoring and Auditing


Understanding the Distinctions: QA vs. QC

We Invest In Our Employees

National Volunteer Month

Applying Lean Methodology Practically

How to Generate Consistent Work as A Consultant

Strategies for Combating Education Bias in Regulatory Workspaces

Explore the Pathway to Consultancy

Importance of Equity in Healthcare

Transitioning From The FDA To Industry

Remediation & Continuous Improvement

Happy Founder's Day, FDAQRC!

F2F 2022: Folly Beach, South Carolina

Avoid Common Mistakes When Submitting Your Expenses in BigTime

FDAQRC Experiments with a Four-Day Work Week

Taking Preventative Action on Regulatory Compliance Processes

The War For Talent Continues

A Road Map To Improve Quality Culture

No Regrets with Vendor Qualifications

For Cause or Not For Cause

A Day in the Life of a FDAQRC Auditor

The Growing Trend Of
Quality & Regulatory Affairs
Quality & Regulatory Affairs

Quantifying the Quality Professional’s Experience


Pharma/Med Device: 2020 Year in Review

Running Your
Business as
a Consultant
Business as
a Consultant
