Pharmaceutical discipline for every BioEdge peptide
From supplier qualification to delivery, our quality system is designed to withstand regulatory scrutiny and deliver reproducible research outcomes.
GMP-aligned partners audited for documentation integrity, change control, and deviation management.
Comprehensive characterization using HPLC, LC-MS, MALDI-TOF, NMR spot checks, and endotoxin analysis.
ISO 9001 framework with CAPA programs, electronic documentation control, and continuous improvement reviews.
Core controls
Lot-specific chain-of-custody tracking from synthesis through final release.
Redundant stability chambers with ICH-compliant monitoring and excursion alerts.
Randomized retention samples stored under validated conditions for re-testing.
24-hour product hold for secondary analytical verification before shipment.
Deviations trigger rapid CAPA investigations with documented resolutions shared transparently.
Environmental monitoring across cleanrooms and staging areas ensures sterility compliance.
Telemetry data from shipments is reviewed post-delivery. Out-of-range events initiate replacement or further testing.
Partner facilities undergo periodic audits and performance scoring to maintain approved status.
Temperature loggers accompany each shipment. Our team reviews telemetry data upon delivery and archives reports for audit readiness.