Providing FDA regulatory compliance to pharma companies
Providing FDA regulatory compliance to pharma companies
We provide comprehensive FDA GxP support for sponsors, CROs, CMOs, and Investigator Sites-delivering global audits, QA systems, and compliance expertise built on 15+ years of industry experience.
QualRS is a Nevada-based GxP consultancy helping biopharma sponsors, CROs, and CMOs stay inspection-ready through risk-based audits, QMS development, and AI-enabled quality solutions.
Global investigator site audits, vendor audits, raw materials/API audits, and regulatory compliance assessments.
We use AI-assisted document review to accelerate preparation — never replacing human expertise, only enhancing efficiency.
CSV, Part 11 assessments, and data-integrity reviews for eTMFs, LIMS, QMS platforms, and other GxP systems.
QMS design, SOP frameworks, gap assessments, and remediation plans after inspections or warning letters.
AI-assisted audits, SOP automation, and GxP chatbots that augment—never replace—sound quality judgment. (Link: Learn More → AI-GxP page)
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“QualRS has been a trusted QA partner for over four years. Their auditors are thorough, professional, and consistently deliver inspection-ready results.”
— QA Director, U.S. Biotech Company
“Their global audit coverage saved us more than 60% in travel costs while increasing audit throughput.”
— Clinical Operations Manager, Ophthalmology CRO
“The addition of AI-supported SOP automation reduced our document backlog by almost 50%.”
— Head of Quality Systems, CMO in California
A sponsor engaged QualRS to conduct multiple GCP audits across the U.S., EU, and Asia.
Result:
All sites inspection-ready within 60 days
Zero critical findings across all audits
Reduced sponsor QA travel by 70%
A biotech needed rapid qualification of multiple vendors ahead of a Phase 2 submission.
Result:
Completed 12 audits in 45 days
Identified two high-risk vendors and recommended remediations
Accelerated the sponsor’s submission timeline
A CMO struggled with SOP backlogs and version inconsistencies.
Result:
Implemented hybrid AI-human SOP drafting
Reduced update cycle from 3 weeks → 5 days
Improved document accuracy and audit readiness
Over 100+ local auditors across the U.S., EU, UK, Japan, India, China, Australia, and LATAM.
This model eliminates travel costs and shortens scheduling timelines—allowing faster, more cost-efficient audit execution.
QualRS is developing a secure, searchable marketplace for pre-qualified GxP compliance audit reports, designed to help sponsors, CROs, CMOs, and quality teams reduce audit duplication, accelerate vendor qualification, and control costs.
Soon, clients will be able to access:
Independent GCP, GMP, and GLP audit reports
Investigator site, vendor, and CMO assessments
Globally conducted audits by experienced, local QualRS auditors
Inspection-ready reports aligned with FDA, ICH, and global regulations
Each report will be reviewed for quality, consistency, and relevance, with site approval obtained prior to publication.
Launching soon.
Interested in early access or notification when the marketplace goes live?
👉 Contact QualRS | [email protected]
