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Quality Assurance and GxP Compliance

Ensure quality compliance from quality management systems (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 Veristat Quality team establishes 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, our 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.

It's never too early to ensure quality.   Let's Talk. 

Quality Assurance Across the Clinical Development and Commercialization Lifecycle

QMS Establishment

  • - Global EU/CH QMS
  • - Defining license scope
  • - Gap assessment
  • - SOP development
quality mangement system (QMS) establishment

QMS Management

  • - Risk assessment and monitoring
  • - CAPA, deviation, change control
  • - Monitoring quality metrics and KPIs
  • - GMP/GDP audits
quality management system (QMS) management

Quality Oversight

  • - Oversight of QMS
  • - Acting as Swiss RP/EU QP
  • - Batch/market release
  • - Complaints and recall management
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Compliance & Inspections

  • -Full quality compliance
  • - Self-inspection audits
  • - Inspection readiness
    - Impact assessment of legislative changes
quality oversight
Home > why-veristat company/about approach company/leadership-team news global-reach-locations careers careers/open-positions veristat-culture-our-core-values careers/explore-benefits careers/life-at-veristat because-we-care why-veristat therapeutic-expertise therapeutic-expertise/oncology therapeutic-expertise/neurology endocrine-metabolic-disease therapeutic-expertise/immunology-and-inflammation therapeutic-expertise/infectious-disease therapeutic-expertise/covid-19 therapeutic-expertise/cardiology therapeutic-expertise/other solutions full-service-cro-biologics cro-cell-gene therapeutic-expertise/vaccines therapeutic-expertise/rare-diseases therapeutic-expertise/pediatric-clinical-trials decentralizedclinicaltrials clinical-trial-rescue-programs services/full-service-solutions clinical-trial-planning clinical-trial-conduct regulatory-submission solutions/natural-history-studies services Services > services/strategic-consulting adaptive-designs services/introduction-statistical-power services/regulatory-affairs-overview services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design services/regulatory-affairs/regulatory-approvals services/chemistry-manufacturing-controls-cmc services/regulatory-affairs/regulatory-agency-meeting-support services/regulatory-affairs/regulatory-publishing regulatory-medical-device-ivd services/clinical-operations services/clinical-operations/project-management services/clinical-operations/monitoring patient-recruitment-for-clinical-trials patient-retention-and-site-engagement medical-affairs-overview services/medical-affairs/safety-pharmacovigilance services/medical-affairs/data-monitoring-committees services/medical-affairs/medical-monitoring-for-clinical-trials services/regulatory-affairs/medical-writing services/biometrics services/biometrics/data-management services/biometrics/biostatistics services/medical-affairs/data-monitoring-committees services/biometrics/statistical-programming services/biometrics/standards-implementation pharmacovigilance services/strategic-resourcing library blog latest-newsletter contact-us rfp quality-assurance Quality assurance


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