QUALITY ASSURANCE
Quality is fundamental to successful drug and medical device development. LBRIA provides independent quality oversight across regulatory submissions, clinical operations, and biometrics. We conduct structured reviews of regulatory documents, medical writing deliverables, biometric outputs, clinical programming, and data analytics to ensure accuracy, consistency, and regulatory compliance prior to submission or inspection.
Our Quality Assurance services support inspection readiness and risk mitigation across all phases of development, including:
GLP audits,
Regulatory submission audits (510(k), IND, NDA, BLA,
Clinical site audits and FDA/EMA inspection readiness audits,
Clinical Study Report (CSR) audits, including tables, listings, and figures (TLFs),
Trial Master File (TMF) audits,
Vendor qualification and oversight audits.
LBRIA conducts routine, for-cause, and study-specific audits across a broad range of clinical and nonclinical service providers, including preclinical vendors, clinical laboratories, and investigational product storage and distribution partners.
Our auditors have global experience supporting sponsor programs across the Americas, Europe, Eastern Europe, Asia, India, Australia, and Africa.
Quality Assurance activities are planned collaboratively with sponsors and regulatory teams to address program-specific risks and regulatory priorities.
In addition to traditional quality assurance services, LBRIA provides expert compliance reviews to support regulatory remediation, inspection response, legal matters, and clinical trial rescue programs.
Our integrated quality and regulatory approach helps sponsors maintain compliance, reduce risk, and support successful regulatory outcomes.
