Quality by Design Frameworks

Improved time-to-market, better product quality, regulatory compliance, cost reduction, less waste, and cycle time reduction. Quality by Design supports it all.

Having a solid Quality by Design framework supported by the latest technology will have a major impact in your business operations.

Our decade of experience and proprietary state of the art software can help you.


Talk to our experts

Quality by Design Frameworks

Improved time-to-market, better product quality, regulatory compliance, cost reduction, less waste, and cycle time reduction. Quality by Design supports it all.

Having a solid Quality by Design framework supported by the latest technology will have a major impact in your business operations.

Our decade of experience and proprietary state of the art software can help you.


Talk to our experts

Identify and understand the critical sources of process variability

Ensure product quality

Reliably predict patient safety and product efficacy

Control the factors that affect product performance

Why

Quality by Design is more than a guideline to comply with. It is the centre piece pharmaceutical development effort. It allows us to fully understand and then consistently meet the patient's needs during the entire lifecycle of the product.

Having a properly designed framework in place will bring your manufacturing to a state of efficiency, agility and flexibility that produces high-quality drug products without extensive regulatory oversight.

...

How

Whether you want to upgrade your Quality by Design process or take a more digital approach to your framework don’t worry – we have you covered.

Our full understanding of a QbD framework implementation and our proprietary technology will help support you with the design space, process-control methodology and the quantitative and qualitative estimates of risk level.

...

Working with us will help you with any or all of these steps:

  • Establishing the quality target product profile
  • Identifying critical quality attributes (CQAs)
  • Identifying critical process parameters (CPPs)
  • Performing the risk assesment of linking material attributes and process parameters (processes, equipment, input materials) to critical quality attributes
  • Characterising design space
  • Understanding and monitoring process variation using Multivariate Data Analysis tools, process analysers, PAT tools and knowledge management platforms
  • Having a structure to manage process capability, control and robustness
  • Characterizing and support qualification of analytical methods
  • Design process-model monitoring and maintenance
  • Characterising raw-material variation
  • Digitalize and integrate any of the previous steps

The stages of product lifecycle that we impact

4TuneEngineering 4TuneEngineering lifecycle

The solutions we work with

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What can you expect when you work with us

  • We will have a Pre-project meeting so that we can understand your expectations in the short and medium-term.
  • When everything is lined-up, and if you are happy, we will enter into contract.
  • Our teams will meet to formalize the project kick-off, covering the project scope, schedule, milestones, deliverables, and anything else that is necessary.
  • We will install the necessary software with any customizations that we may have agreed before.
  • We will define Software training dates for your team in order to make sure you can make the most out of Risk Management Digitalization.
  • We will provide you support and follow-up during our partnership.
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Let's upgrade your Quality by Design Framework

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