At FDAQRC, we provide trusted compliance solutions to pharmaceutical, biotech, and medical device companies around the globe.
Across All GxP
FDAQRC pioneers QP services, ensuring seamless compliance and efficient product release for UK and EU pharmaceutical imports. This expansion underscores their commitment to client satisfaction and regulatory excellence.
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 Trusted Partner in Life Science Consulting
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 product life cycle and development phases.
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.
✓ Global Regulatory Compliance Leader
✓ Expertise Across GxP Areas
✓ Comprehensive FDA Consulting Service
✓ Advanced Consultant Network
✓ Personalized Consulting
✓ Excellence in Regulatory Compliance
✓ Tailored Solutions
✓ Client-Centric
✓ Trusted Partner
Pharmaceutical Compliance Consultants With Global Expertise
FDAQRC proudly boasts a global consultant network, demonstrating our dedication to top-tier service in quality and regulatory compliance. With over a decade of experience in 70+ countries and over 500 active consultants globally, 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 ˄
Where Expertise Meets Excellence
FDAQRC emphasizes global quality and compliance solutions. Our expertise and science-backed processes can provide optimized outcomes for pharmaceuticals, medical devices, and biotechnology throughout each product’s life cycle.
Why Leading Companies Choose Our FDA Quality and Compliance Consultants
You can trust FDAQRC to handle all areas of your project compliance because of our:
- Global expertise: Since 2009, FDAQRC has continued to grow. This consistent development means we now have over 500 consultants across more than 70 countries.
- FDA expertise: FDAQRC is passionate about maintaining our quality assurance and compliance leadership. Our experts remain current with FDA requirements and expectations to provide trusted services to our clients.
- Comprehensive GxP coverage: We follow your product through every stage of the life cycle — from research to the market — to uphold compliance. This service extends to all areas of life sciences, including manufacturing, clinical, and laboratory settings.
- Personalized approaches: Throughout our years in the industry, we have recognized that every project deserves a unique approach. Our pharmaceutical quality consultants can tailor your experience in accordance with global standards, wherever you are in the world.
Pharma and MedTech Consulting Excellence
Our FDA consulting services include expert GxP compliance and quality assurance. Our customized, value-added solutions can optimize your efficiencies while minimizing regulatory risks.
✓ Our GxP Compliance Services:
FDAQRC combines our expertise with cutting-edge science to eliminate pathogens, promote safety and improve the shelf life of your products. We are proud to be a leader in GxP compliance, meeting industry quality standards and providing end-to-end GxP compliance support.
We utilize the following regulations and FDA compliance services to maintain compliance throughout your product’s life cycle:
- Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP)
- Good Laboratory Practice (GLP)
- Good Clinical Lab Practice (GCLP)
- Pharmacovigilance services (GVP)
- Computer System Validation (CSV)
- Good Distribution Practice (GDP)
✓ Our Quality Assurance Services:
Quality assurance is more than meeting regulatory requirements — it’s about building trust with your consumers and healthcare professionals. FDAQRC can assist your product development through post-market surveillance with the following services:
- Qualification and validation services
- Inspection readiness
- Remediation services
- Life sciences recruitment
Take Your Quality and Compliance to the Next Level
At FDAQRC, our mission is to provide technical expertise to advance life science solutions. With risk-based assessments and regulatory compliance standards, we can work together to improve the health and welfare of the global population. Contact us today to schedule a personalized consultation.
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
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?
Explores the Differences Between Auditors and Inspectors in the Clinical Research Industry
Despite similarities and differences in their roles, both auditors and inspectors play an important part in ensuring compliance.
Competency Based Programs Contribute to Early Clinical Research Professional’s Training
Explore the benefits of on-the-job training for Clinical Research Professionals
15 Years of Excellence: FDAQRC's Journey and Future Vision
Marking a milestone of 15 years, FDAQRC continues to grow with expanded global services, innovative partnerships, and steadfast commitment to quality and compliance.
Tips for a Positive Outcome While Performing a Challenging Audit
Transform a daunting audit into an opportunity for improvement with strategies to de-escalate tensions and foster collaboration
How To Find Qualified Patients for Your Clinical Trials
Streamline patient recruitment and match participants to your specific research criteria with Quri.AI’s advanced AI-driven solutions. Save time, reduce costs, and enhance the success of your clinical trials.
Simplified SOPs Can Reduce FDA Citations and Enhance Compliance Culture
Failure to fully adhere to Standard Operating Procedures (SOPs) is a leading cause of FDA warning letters, with over half of the citations issued annually addressing this concern.
Creating a Supportive Workplace: Recognizing and Addressing Mental Health
Fostering well-being in the workplace involves raising awareness and encouraging self-care. Implementing strategies to prevent burnout and support mental health is essential for a positive, inclusive environment..
AI in Clinical Trials: Transforming Research and Regulation
Exploring AI's Role in Streamlining Clinical Trials, Addressing Regulatory Complexity, and Balancing Ethical Considerations
FDAQRC's Retreat and Reconnect
Our team experienced the wonders of Costa Rica while strengthening team bonds and making memories at the 2024 Face-2-Face annual meeting.
Pharmacovigilance: Insights, Challenges, and Future Horizons
Navigating drug safety with a focus on insights, challenges, and digital innovations for a safer future.
The Future Looks Bright
Unveiling a year of achievements, growth, and industry connections - FDAQRC sets the stage for a thriving future in 2024.
FDAQRC Named a 2024 Aggie 100 Honoree
FDAQRC is among the top 100 companies globally selected for the 19th annual Aggie 100 which honors the fastest-growing companies owned or led by Texas A&M Alum.
Celebrating 14 Years of Excellence
FDAQRC recaps a year of achievements as we celebrate 14 years in business as of October 2023!
Mastering the Difference: Monitoring and Auditing
Pharmaceutical research sponsors must make sure they follow both Monitoring and Auditing rules during their studies - so what's the difference?
Understanding the Distinctions: QA vs. QC
While these terms are sometimes used interchangeably, it is important to understand their distinctions and the specific protocols associated with each area.
We Invest In Our Employees
At FDAQRC, we understand that the best business practices must start with our employees.
National Volunteer Month
During the month of April, FDAQRC encouraged employees to donate or volunteer. Read about the impact our team made!
Applying Lean Methodology Practically
Lean Methodology is a way of optimizing the people, resources, effort, and energy of your organization toward creating value for the customer.
How to Generate Consistent Work as A Consultant
Generating consisting work seems to be a common struggle our network is seeing. Here are a few tips to set yourself up for success as a consultant and increase your number of projects.
Strategies for Combating Education Bias in Regulatory Workspaces
This downloadable poster elaborates on the problems surrounding education bias in the biopharmaceutical industry.
Explore the Pathway to Consultancy
This downloadable poster presents the clear steps of how to become a consultant while evaluating if consultancy is the best fit for someone’s experience and career goals.
Importance of Equity in Healthcare
In honor of Black History Month we explore the need for equity in healthcare. The foundational goal is to ensure that everyone has fair access to healthcare and the right to be the healthiest version of themselves.
Transitioning From The FDA To Industry
Transitioning from the FDA into the industry can be an overwhelming experience. Here are some tips to keep in mind when entering a new role outside of the FDA.
Remediation & Continuous Improvement
Jim Darnell, Director of Remediation, presents the importance of Remediation & the Continuous Improvement process.
Happy Founder's Day, FDAQRC!
On October 12, 2022, FDAQRC will be celebrating 13 years of business. We thank our internal team, our clients, and our consultants, for our continued success!
F2F 2022: Folly Beach, South Carolina
Each year the FDAQRC team meets up for a Face-2-Face meeting. This year, our team meet up in Folly Beach, SC to look back, reflect, and plan for the future!
Avoid Common Mistakes When Submitting Your Expenses in BigTime
At FDAQRC, our consultants are a vital part of our business model. We pride ourselves on ensuring our consultants have the tools they need to succeed.
FDAQRC Experiments with a Four-Day Work Week
The new schedule was meet with an overwhelmingly positive response.
Taking Preventative Action on Regulatory Compliance Processes
FDAQRC can identify trouble areas in your compliance processes and design a plan to correct it - leaving you prepared and confident for an FDA inspection.
The War For Talent Continues
With no end in sight, FDAQRCandidates was created to help both employers and employees in this super competitive market
A Road Map To Improve Quality Culture
First presented at SQA 2022 FDAQRC’s Project Manager, Amanda White examines how poor-quality culture can take a toll on your organization.
No Regrets with Vendor Qualifications
What's required, how to begin, and how to maintain vendor qualifications.
For Cause or Not For Cause
The best way to ensure that your firm is inspection ready at all times is to be proactive in preventing “for-cause” inspections and make the reactive approach the “not to be."
A Day in the Life of a FDAQRC Auditor
From a flexible work schedule to health insurance, FDAQRC values each and every employee, but the one we’re most proud of is the fact we allow our Auditors to do what they do best, audit.
The Growing Trend Of
Quality & Regulatory Affairs
Quality & Regulatory Affairs
The advantages of Outsourcing vs. Developing In-House Capabilities
Quantifying the Quality Professional’s Experience
Try not to rely on the quantity of audits an auditor has performed, it goes against the concept of quality over quantity.
Pharma/Med Device: 2020 Year in Review
In arguably the most challenging period in modern history, the pharmaceutical and medical device industries carried on in the face of disruption to personnel, supply chains, travel, and many more critical business areas due to the Covid-19 pandemic.
Running Your
Business as
a Consultant
Business as
a Consultant
Tips, tricks, and best practices to make the most of your business.
Is Your QMS Ready
For ISO 13485:2016?
Review the five commonly asked questions from the industry regarding the transition to 13485:2016.