Qualification of BR / BT Site
Qualification and audit of bioequivalence (clinical) and bioanalytical (BR/BT) study sites for dossier acceptability.
Overview
Bioequivalence and bioanalytical data are pivotal for generic and many product approvals — and regulators scrutinize the sites that generate them, with a history of inspections that have invalidated data and triggered application-wide consequences. PharmExpert qualifies and audits bioequivalence (clinical) and bioanalytical (BR/BT) study sites so the data they produce is reliable and acceptable to your target agencies.
On the clinical side, we assess the bioequivalence study site against GCP — subject protection, conduct against protocol, source data and investigational-product control. On the bioanalytical side, we assess the laboratory against GLP and bioanalytical method-validation expectations, including ICH M10.
Data integrity runs through both. We examine whether study and bioanalytical data are attributable, contemporaneous and trustworthy, since data-integrity concerns at BA/BE sites are a recurring cause of rejected data.
The output is qualification and audit reports that support confident site selection and defend the resulting data in your dossier. Whether you are choosing a CRO for a BA/BE program or assuring data already generated, the audit protects the pivotal evidence your approval rests on.
What we do
- Bioequivalence (clinical) site qualification and audit
- Bioanalytical laboratory qualification and audit
- GCP / GLP and method-validation assessment
- Data-integrity review of study and bioanalytical data
- Site-selection support for BA/BE programs
- Qualification and audit reporting for the dossier
Our process
- 1
Scope
Define the BR/BT sites and applicable standards.
- 2
Assess
Audit clinical and bioanalytical facilities and data.
- 3
Qualify
Determine acceptability and gaps.
- 4
Report
Deliver qualification/audit reports for the dossier.
What you receive
- BR/BT site qualification and audit reports
- GCP/GLP and method-validation findings
- Data-integrity assessment
- Site-acceptability recommendation
Who needs this
Generic and product developers selecting BA/BE and bioanalytical sites, and teams needing assurance that pivotal BE data will be accepted by regulators.
Frequently asked questions
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