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INDUSTRIES

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Our team of experts is dedicated to providing tailored solutions that address the unique challenges of each industry, helping our clients to achieve their quality and productivity goals.

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The Industries We Serve

CELL AND GENE THERAPY
  • Quality Investigations resolution and backlog reduction

  • Process characterization and value stream mapping, for manufacturing and supply chain

  • Highly-visual procedures and job aids for manufacturing, facilities, utilities and supply chain

  • Risk-based product development

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cellandgene
BIO TECH AND VACCINES
  • Quality Investigations resolution and backlog reduction

  • Process characterization and mapping

  • Value stream mapping

  • Development of trainings material to prevent recurrence of non-conforming events

  • NDA submission documentation

  • Database development to support NDA submission

  • CAPA project management and execution

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biotechvaccines
medicaldevice
MEDICAL DEVICE AND ROBOTICS
  • Quality Investigations resolution and backlog reduction

  • Risk management implementation and roll-out

  • Product development process and quality systems characterization and improvement, for instruments, reagents, consumables, panels and software

  • Product and process architecture diagrams

  • Cloud database design and application development, for data, risk and change management

  • Highly-visual procedures and training materials for increased quality in manufacturing floor

  • Manufacturing execution systems (MES) modeling and implementation support

  • Quality Investigations resolution and backlog reduction

  • Risk management and process characterization

  • Risk-based improvements to manufacturing steps

  • UML activity diagrams for process characterization, manufacturing and software operations

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