Project Manager Working with Their Auditing Team

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

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.

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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

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

Let's Connect

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

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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.

Learn More About FDAQRC

✓ 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

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.

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˄ 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 pharma 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 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.