Other Therapy Areas

Extending our scientific depth across allergy, dermatology, ophthalmology, respiratory, women's health, and more.

Learn More →

    Home > why-veristat company/about approach veristat-press-coverage corporate-responsibility news events global-reach-locations 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/rare-diseases therapeutic-expertise/pediatric-clinical-trials decentralizedclinicaltrials services/full-service-solutions clinical-trial-planning clinical-trial-conduct regulatory-submission solutions/natural-history-studies services Services > regulatory-writing-services-old services/strategic-consulting services/introduction-statistical-power services/regulatory-affairs-overview services/regulatory-affairs/regulatory-approvals services/chemistry-manufacturing-controls-cmc services/regulatory-affairs/regulatory-agency-meeting-support services/regulatory-affairs/regulatory-publishing services/clinical-operations services/clinical-operations/monitoring patient-recruitment-for-clinical-trials patient-retention-and-site-engagement medical-affairs-overview services/medical-affairs/medical-monitoring-for-clinical-trials services/biometrics pharmacovigilance quality-assurance-and-compliance services/strategic-resourcing library blog latest-newsletter contact-us rfp quality-assurance Quality assurance

     

    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
    people_working_handsoverpapers

    Compliance & Inspections

    • -Full quality compliance
    • - Self-inspection audits
    • - Inspection readiness
      - Impact assessment of legislative changes
    quality oversight
    Home > why-veristat company/about approach veristat-press-coverage corporate-responsibility news events global-reach-locations 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/rare-diseases therapeutic-expertise/pediatric-clinical-trials decentralizedclinicaltrials services/full-service-solutions clinical-trial-planning clinical-trial-conduct regulatory-submission solutions/natural-history-studies services Services > regulatory-writing-services-old services/strategic-consulting services/introduction-statistical-power services/regulatory-affairs-overview services/regulatory-affairs/regulatory-approvals services/chemistry-manufacturing-controls-cmc services/regulatory-affairs/regulatory-agency-meeting-support services/regulatory-affairs/regulatory-publishing services/clinical-operations services/clinical-operations/monitoring patient-recruitment-for-clinical-trials patient-retention-and-site-engagement medical-affairs-overview services/medical-affairs/medical-monitoring-for-clinical-trials services/biometrics pharmacovigilance quality-assurance-and-compliance services/strategic-resourcing library blog latest-newsletter contact-us rfp quality-assurance Quality assurance


    Ready to develop your quality assurance strategy?

    LET'S TALK

    Learn More with These Resources

    Podcast

    Scope of Things Podcast: Daphne Smyth on the Chinese Drug ...

    Blog

    Measuring what cant be seen how ptsd clinical trials prove a ...

    Webinar Video Replay

    Days Instead of Weeks: What It Actually Takes to Close the ...