Your Worldwide
Compliance Partner

Where Expertise 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.

INDUSTRY INSIGHTS