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


Ready to develop your quality assurance strategy?

LET'S TALK

Learn More with These Resources

Fact Sheet

Rare Disease Fact Sheet

Blog

Regulatory Guidance Monthly Review - February 2024

Blog

Regulatory Guidance Monthly Review - January 2024