REGULATORY
Engineered to satisfy regulated environments.
Bastion Applied Sciences supports clients whose products, filings, and reputations depend on defensible science. Our operations are engineered to satisfy the expectations of major regulatory frameworks and the inspectors who enforce them.
REGULATORY DISCIPLINES
Operations engineered to support FDA expectations for laboratory quality, documentation, and data integrity.
Current Good Manufacturing Practice principles applied to method, process, and record control.
Good Laboratory Practice concepts inform study conduct, reporting, and archival.
Awareness of Good Clinical Practice expectations where laboratory data supports clinical decisions.
ICH Q9-inspired risk assessment integrated into method development, change control, and CAPA.
Records, personnel, and procedures maintained in a continuously inspection-ready state.
Complete, contemporaneous, and reviewable — because a study's defensibility lives in its documentation.
Validation is a lifecycle: intended use, risk, execution, and periodic re-evaluation.
References to FDA, cGMP, GLP, and GCP describe frameworks our operations are engineered to support. Regulatory registrations, inspection outcomes, and formal compliance status are communicated only where independently confirmed.