Why is it important?

Taking a drug product from development into commercial production is a fantastic achievement. Now, every hour is of importance in terms of reaching the final goal: entering the pharmaceutical market.

With a carefully planned regulatory strategy it may be possible to save time in your final preparations.

You could need support with things that are challenging in terms of time, costs and human resources :

  • validation planning
  • timing of validation batches
  • bracketing design

Several functions will need to be involved to ensure the most efficient and sustainable solutions, including quality assurance, GMP, regulatory affairs etc.

Once you are in the commercial phase and routine production has started, you may find that changes to either the manufacturing process or the regulatory documentation are necessary.

Why use our support with commercial production?

Arex Advisor can do the following:

  • offer advice on how to structure your variation application
  • plan potential studies
  • write the technical documentation
  • submit the eCTD files
  • help with changes to manufacturing processes such as scale-up, tech-transfer, changes to in-process controls and specification limits

To reduce your risks, we can arrange more opportunities for communication with the health authorities, for example through scientific or regulatory advice meetings etc.

What is the result for you and your project?

In general, our assistance will result in a thorough evaluation of the manufacturing and control process, potentially simplifying or improving it to reduce costs or bolster robustness. The combination of our experience with formulation strategy, quality assurance and regulatory affairs will be of use to you at any stage of the development or commercialization journey.

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