Pharma and Biotechnology

Towards predictive and individualised medicine.

What we can do to detect illness before the person actually becomes ill? That is medicine’s challenge for the future.

Areas of expertise

Area of expertise

  • Analytical method development
  • Laboratory engineering
  • Formulation
  • Bioprocess development

References 

  • Bioprocess development: a consultant has been working in the Product Development department, conducting analysis using protein-based methods, as well as developing methods and calibrating instruments.
  • Bioprocess development: our consultant is a part of the R&D department, where he prepares and evaluates DNA, works with mammalian cell cultures and generates material for further studies.

Area of expertise

  • Quality assurance
  • Quality control
  • Regulatory affairs

References

  • Quality assurance: a consultant is currently supporting the Quality Assurance team for clinical production batches, handling CAPA, deviation management, and SOP updates.
  • Quality control: a team of consultants have been supporting Merck with QC laboratory development, from establishing laboratory equipment specifications and following-up procurement, to qualification and drafting SOPs.
  • Regulatory affairs: a consultant supported the Regulatory department by preparing documentation and working towards the product introduction on the market.

Area of expertise

  • Supply Chain management
  • Purchasing
  • Lean Manufacturing
  • Logistic

References

  • Project management and serialisation: a consultant has been writing technical specifications for vision and marking systems, as well as liaising with suppliers and conducting equipment commissioning.

Area of expertise

  • Process engineering
  • Qualification & Validation (equipments & systems)
  • Cleaning validation
  • Automation engineering
  • Lean Manufacturing

References

  • Process validation: a consultant is helping to validate two New Product Introductions, scale-up product manufacturing, carry out risk assessments and SOP validation, and conduct employee training.
  • Validation: our consultant is working on a migration project that emcompasses hundreds of IT-systems, tasks are mainly centered around GAP-analysis, Installation and functionality tests etc. Collaborates with a wide array of functions within many different work units, for example Quality Assurance, SYstem engineers, System owners, Project managers etc.

Area of expertise

  • Project management R&D or engineering
  • Cost control / planning / risk management

References

  • Project management and serialisation: a consultant has been writing technical specifications for vision and marking systems, as well as liaising with suppliers and conducting equipment commissioning.

They trust us

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