BA/BE centre approval applications and facility readiness
A bioavailability and bioequivalence centre must be approved by CDSCO before it can conduct studies whose data will support a regulatory submission. Approval follows an inspection covering the clinical facility, the bioanalytical laboratory, standard operating procedures, staff qualifications and the registered ethics committee.
| CDSCO inspection | Joint inspection precedes approval |
|---|---|
| Ethics Committee | Must be separately registered |
What the inspection actually looks at
Two facilities are assessed, and they are judged differently. The clinical unit is examined on subject safety: bed capacity, emergency equipment and drugs, medical cover, screening procedures, housing and dietary control, and the volunteer registry that prevents overlapping participation.
The bioanalytical laboratory is examined on data integrity: instrument qualification, method validation, chromatographic data system audit trails, sample storage and chain of custody, and whether the raw data can be reconstructed independently of the summary report.
Audit trail review is where most findings land. A laboratory that cannot demonstrate who changed what and when will not pass, regardless of how good its science is.
Getting a facility ready
We walk the site against the inspection scope and produce a gap list with owners and dates. Typically that covers SOP coverage and version control, qualification and calibration records, training files, the archival system, and the ethics committee's own registration and composition.
Where a facility is being built or expanded, it is materially cheaper to involve us at layout stage than after commissioning.
Maintaining approval
Approval is not permanent. Reinspection, changes in key personnel, changes in scope and equipment replacement all have consequences, and a centre that lets its documentation drift between inspections carries real risk to every sponsor using it.
What you need to supply
- Site layout drawings for the clinical unit and the bioanalytical laboratory
- SOP index with version control status
- Equipment list with qualification and calibration records
- Curricula vitae and training records for key personnel
- Ethics committee registration certificate and constitution
- Volunteer registry and screening procedure
Questions we get asked
How long does BA/BE centre approval take?
The elapsed time is dominated by inspection scheduling and by how many observations the first inspection raises, rather than by review of the application itself. A facility that has been prepared against the inspection scope in advance closes out considerably faster than one that has not.
Does our ethics committee need separate registration?
Yes. The centre's approval and the ethics committee's registration are two different approvals with two different applications. A centre cannot rely on an unregistered committee, and this is a common finding at inspection.
Can a contract research organisation apply, or only a sponsor?
The centre itself applies, whether it is an independent contract research organisation or a facility within a larger company. The sponsor of any individual study is a separate matter and does not affect the centre's approval status.
This page is orientation, not advice on your specific product. Statutory periods, fee schedules and compliance deadlines change. Confirm the current position before you plan around it. Last reviewed 23 August 2026.