Providing FDA regulatory compliance to pharma companies
Providing FDA regulatory compliance to pharma companies
Conducted a multi-national audit to ensure site compliance and data integrity for a high-stakes ophthalmology clinical trial.
Prepared a clinical site for a successful FDA BIMO inspection through gap analysis and intensive staff training.
Redesigned SOPs and internal quality processes for a biotech firm to streamline global regulatory submissions.
Evaluated adverse event reporting workflows to ensure 100% compliance with international safety reporting standards.
Conducted rigorous vetting of a global CRO to confirm technical capabilities and adherence to GCP standards.
Led a root-cause analysis and remediation plan following a major audit finding, preventing future regulatory delays.
Description: Performed a comprehensive validation of a cloud-based eClinical SaaS platform to ensure 21 CFR Part 11 compliance and robust data encryption for a mid-sized pharmaceutical client.
Description: Audited a global cold-chain logistics provider to verify adherence to GDP standards, focusing on temperature monitoring, storage security, and international transport protocols.
Description: Executed a series of onsite raw material audits for a medical device manufacturer to mitigate contamination risks and ensure supply chain traceability from source to production.
Description: Guided a startup through the GAMP 5 framework to validate their proprietary analytics software, ensuring the system met rigorous quality standards before its commercial launch.
Client: U.S.-based Private Equity Group (Confidential)
Engagement: Pre-acquisition compliance diligence of a multi-site CRO platform—clinical operations across several U.S. states and bioanalytical laboratory capabilities in Switzerland.
QualRS Role:
Clinical Infrastructure Assessment (U.S.): Led by Debbie, QualRS GxP Compliance SME
Bioanalytical Lab Assessment (Switzerland): Led by Mike, Bioanalytical/GLP Quality SME
What We Evaluated:
QMS maturity (CAPA, deviations, change control, training, documentation)
Inspection readiness and operational execution
Data integrity and computerized system controls (risk-based)
Bioanalytical method governance, equipment qualification, and sample chain-of-custody
Result:
Both assessments concluded the target maintained a strong, well-controlled compliance environment with no material red flags—a clear “thumbs up” for acquisition readiness.
Value to the Investor:
QualRS delivered an evidence-based diligence summary and debrief that translated GxP findings into transaction-relevant risk, supporting investment decision-making and post-close scalability planning.