AssurX
configurable enterprise quality and regulatory-compliance software for pharmaceutical, biotech and medical-device organizations, including FDA QMSR-transition and ISO 13485-aligned inspection-readiness support.
- Country
- United States
US
Coverage
| US | |
|---|---|
| digital-it | ✓ |
Regulatorsfdaema
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Quality management systems (QMS) for biologics | digital-it | Low | → |
Compiled by BIOECON via the bioecon-brief pipeline.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.