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FDA Quality + Regulatory Consultants, LLC A fresh perspective. Trusted compliance solutions. u

The right compliance solution

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Global independent experts

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A personal leadership team

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Home-based Project Manager


We do more than audits. We collaborate with you to analyze your need and match the right expert to your situation.


FDA Quality + Regulatory A fresh perspective Consultants, LLCsolutions Trusted compliance

A fresh perspective. Trusted compliance solutions.

The right compliance solution

Global independent experts

FDA Quality and Regulatory Consultants LLC offers specialized global quality and regulatory consulting for pharmaceutical, medical device and biotech companies. We do more than audits. We collaborate with you to provide tailored, innovative solutions for your quality, training and compliance challenges utilizing a scale up / scale down approach for cost control.

Our global team includes former Food and Drug Administration (FDA) national experts, field investigators, compliance officers and center personnel, as well as global industry experts in quality assurance and regulatory affairs. We provide expert advice to pharmaceutical, medical device and contract research organizations across pre-clinical, clinical and commercialized sectors.

A personal leadership team

Home-based Project Manager

Every member of our leadership team has deep industry experience. We will review your situation and ensure the right expert is matched to your project. When you contact us, we will work quickly to understand your needs. While a Project Manager will be assigned to oversee day-to-day operations, you can always reach out to the leadership team, if needed.

We understand keeping your project on-track requires proactive, real time communication. A home-based Project Manager will be assigned to your team as your point of contact to oversee the project. He or she will be in the office and accessible to ensure your questions are answered quickly, deliverables are of high quality and provided on time.

Customer service is what makes us successful and we aim to exceed expectations.


Customized solutions may include: u

GcLP/ CLIA Clinical Laboratories and GLP Non-Clinical Laboratories Audits

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GCP Phase I and Investigator Site Audits

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GxP Computerized Systems Evaluation and Audit

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GxP Document Reviews and GCP Trial Master File Audits

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GxP Global Agency Response Guidance and Support

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GxP Mock Inspections and Readiness Activities

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GxP Quality Management System Development and Gap Analysis

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GxP Risk Evaluation, Consulting and Hotline Support

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GxP Training


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GxP Vendor Qualification and Audit

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In-Process GMP Facility Audits

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Safety and Post-Marketing Pharmacovigilance Services and Audit

FDA Quality + Regulatory Consultants, LLC A fresh perspective. Trusted compliance solutions.

Contact Us: info@fdaqrc.com | +1 (214) 529-0248 | www.fdaqrc.com

PCSglobal A risk-based Pharmacovigilance solution provider An FDAQRC Company | www.pcsglobal.org

FDA Quality + Regulatory Consultants LLC  

Brochure for FDA Quality + Regulatory Consultants LLC

FDA Quality + Regulatory Consultants LLC  

Brochure for FDA Quality + Regulatory Consultants LLC

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