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Global Expertise Expertise
Across All GxP

At FDAQRC, we provide trusted compliance solutions to pharmaceutical, biotech, and medical device companies around the globe.
About Us
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New! Now Offering FDAQRC Introduces QP Services for UK/EU Drug Releases

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.
BioSpace Article
New Service! Quality Candidates
For Quality Jobs

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.
FDAQRCandidates
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We're Hiring Join Our Growing Team

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.
Careers
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Let's Connect Contact Us Today

Have a question or want to discuss an upcoming project? Send us a message today.
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Your Worldwide
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

Service Offerings

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.

QUALITY MANAGEMENT SYSTEM (QMS)

GOOD CLINICAL PRACTICES (GCP)

GOOD LABORATORY PRACTICES (GLP)

GOOD CLINICAL LABORATORY SERVICES (GCLP)

GOOD MANUFACTURING PRACTICES (GMP)

GOOD MANUFACTURING PRACTICES (GMP)

GOOD PHARMACOVIGILANCE PRACTICES (GVP)

INSPECTION READINESS SERVICES

COMPUTER SYSTEM VALIDATION (CSV)

RECRUITMENT SERVICES

*NEW!* QUALIFIED PERSON (QP)

Global Consultant Network

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.

“The mock inspectors are challenging our audit
logistics in addition to our Quality Systems,
Clinical Operations and overall compliance.”
QA AUDIT MANAGER
“Consultant deliverable are
above expectations.”
SENIOR DIRECTOR, CLINICAL QUALITY ASSURANCE
“I think the FDAQRConsult is fabulous. I do love how
comprehensive it is. This is the kind of information
and resources I love to have for every audit I perform.”
CONSULTANT
“Working with FDAQRC gave me the
opportunity to develop a strategy to
move things forward.”
CONSULTANT
“FDAQRC was very cooperative, easy to work with
and very accommodating. They handled all of the
administrative details, which was very helpful. All interactions
were professional and collaborative.”
R&D QA, GLOBAL DIRECTOR
"I can always count on FDAQRC for a
prompt and helpful response."
GxP EXPERT ADVISOR
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INDUSTRY INSIGHTS