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We Provide Full QA Pharma Support for your Company at Every Stage

including your QA Medical practices to help secure approval for your product

Let’s talk!

Partner with us and we’ll help you to:

  • Solve your QA pharma challenges
  • Ensure compliance with regulatory organizations
  • Secure approval for your product

    Quality AssuranceEarly StagePre-clinicalClinicalRegistrationMarket
    Build QA Systems Establish quality management systems
    Perform gap assessment for the current Quality Management System (QMS), including computerized systems and data integrity capabilities
    Quality oversight of manufacturing activities
    Quality oversight of QC activities (including support with analytical and bioanalytical method development and review of analytical method qualification/validation protocols and reports)
    Qualification and periodic evaluation of service providers (including onsite/remote audits of CMOs, CROs, Analytical Laboratories, etc.)
    Review and establish quality agreements with service providers.
    Provide ongoing QA support remotely and/or at client’s offices (including master and executed batch records review, batch release, etc.)
    Simulate Inspections. Hold mock inspections to prepare for European and FDA pre-approval inspections
    Lead and support inspection readiness and risk assessment processes
    Prepare quality improvement plans
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