Process Scale-up Strategy and Implementation

It's finally time to scale-up your process!

In order to make the most out of it and to ensure highest-standards of quality in the shortest time-span possible, you need a solid strategy and implementation plan.

We can help you with that.


Talk to our experts

Process Scale-up Strategy and Implementation

It's finally time to scale-up your process!

In order to make the most out of it and to ensure highest-standards of quality in the shortest time-span possible, you need a solid strategy and implementation plan .

We can help you with that.


Talk to our experts

Reduced

time-to-market

High standards

of process and product quality 

Data-based

process design decisions 

ICH and FDA  

Guidelines Compliance   

Why

Scaling-up is excellent news, you’re getting closer to bringing your product to the market.  

Having the right strategy to bring your process to pilot and commercial scale can have a strong impact in your time-to-market, in your product quality and, of course, in your process yield – and all of this makes your process an asset to the business of your company.

 
...

How does it work

We believe in well-designed experiments, which are carefully planned and thought out from the outset of formulation development – experiments that will produce quality data from an early stage – which can minimize lengthy and costly repetition of scale-up activities.

We use that data to characterize the process, how the process should evolve, what is critical and must be controlled.

...

When we’re done, you will have:

  • Identified the CQAs of the product and how they can be controlled. 
  • Determined the quality attributes of the drug substance and its drug substance and drug product. 
  • Defined an appropriate manufacturing process and its critical process parameters (CPPs). 
  • Established a control strategy for the process.

The stages of product lifecycle that we impact

4TuneEngineering 4TuneEngineering lifecycle

The solutions we work with

consulting irisk riskregister isee
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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.
software-print

Let's move your process to next the stage!

Talk to our experts