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Quality Systems 

  • Project Management, Scheduling and Controls

  • Worldwide Regulatory Filing Strategies/Filing Documentation Reviews

  • Quality Engineering Supplier audits and Qualifications

  • Quality Technical Reviews & Complaints

  • Audit, Inspection and PAI Readiness

  • Certified Quality Auditors

  • Inspection Readiness

  • Remediation Plans

  • Quality Risk Management, Training & Certifications

  • Risk Based Project Prioritization

  • Data Integrity

  • Regulatory Compliance and Quality Systems/Quality by Design

  • Consent Decree Management

  • Complex Investigations Scientific​

  • Technical & Engineering Training

  • Certification Programs

  • Quality by Design (QBD)

  • Quality Risk Management Analytical and Micro Support.

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