Quality assurance & GxP compliance
Ensure quality compliance from QMS establishment to quality oversight of marketed products.
Based on in-depth and long-term experience, we provide strategic and hands-on operational QA support to pharmaceutical and biotech companies marketing and developing drugs, biologics and gene therapy products.
The SFL Quality team establishes quality management systems (QMSs) for both headquarters and affiliates. We prepare establishment license applications and provide full inspection readiness services. We also support QMS maintenance by auditing client and contractor facilities (including CMOs) for qualification and re-qualification purposes. Furthermore, SFL team members ensure quality oversight of marketed products by acting as EU qualified person (QP), local Swiss responsible person (RP) and/or deputies on a mandate basis.