Qbex Clinical GmbH is a clinical and regulatory consultancy company that was established by Dr. Alexander Hoenel in Austria in 2014, and enlarged for clinical development in 2018. Qbex provides regulatory services to the biotech and pharma industry that span all phases of clinical development, classical CRO services as well as training and assistance in the start up process of Pharmaceuticals and Medical Devices, Audits and QA.
Main task in the project
In WP 9, Qbex will support the consortium partners to develop a clear, comprehensive and efficient path for achieving regulatory compliance for their product development. All the SMEs as well as most of the academic partners have already received ISO certification related to their research and development processes. Nonetheless, at the beginning of the project, Qbex will perform an on-site audit (by a Qbex-accredited auditor) on each site involved in the products production. This audit will focus on all systems and processes that are used in the context of the project (e.g. Quality Management System). Based on the outcome of those audits, Qbex will provide technical advice to partners to improve their quality system and adjust them to the products envisioned in the project.
At the final stage of the project Qbex will:
- Perform a GMP/GCP Mock Inspection on each site involved in the product production. During the project length, Qbex will support implementation of GMP process and afferent QM system. Qbex will provide guidelines and recommendation related to QM system operation to all partners.
- Support and advise the consortium partners in defining strategies and processes for approval of the complex new gene activated matrix therapeutic envisioned by the consortium, from regulatory requirements, to first in human.