PHARMACEUTICAL– Quality Solutions

Quality Management Systems

  • Quality system creation and/or remediation
  • Strategic assessment, compliance, gap and optimization
  • New standards and regulation optimization (EUMDR, MDSAP, etc.)
  • Quality and compliance audits
  • Medical device regulation training

Quality Systems

  • Risk Management
  • Design Controls
  • Combination Devices
  • Document Controls
  • Purchasing controls: supplier controls & audits
  • Manufacturing and operations change management
  • Process validation
  • Acceptance activities
  • CAPA
  • Device listing and complaint handling

Crisis Management, Acquisition and Agency Support

  • Device listing and complaint handling
  • Formulating responses to 483s and Warning Letters
  • Interim QA leadership to guide through crisis management situations
  • M&A due diligence
  • Quality systems acquisition integration planning

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