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CMC Consultancy.

Smart dossier planning for production and beyond.

New product submissions, extensions or changes in manufacturing (manufacturing or analytical transfer changes in quality parameters, etc.)  require the creation or up-date of the chemical manufacturing and control (CMC) module (M3) of your dossier.

Our consultants can offer all the advice and support you need to create or change all the relevant CMC documents to support submissions. Our team have extensive experience working directly in manufacturing plants and understand exactly what is required in your dossier regarding quality, manufacturing, and supply processes.

Combining regulatory intelligence with GMP guidelines creates compliant and smart documentation that is designed to meet authority requirements and reduce the level of impact from future changes.

We do this by:

  • Translating legislation into clear requirements specific to the type of product.
  • Apply our latest knowledge to continuously improve dossier content.
  • Create smart content to avoid additional requests from authorities and to minimize changes with possible regulatory impact throughout the lifecycle of your product.
  • Ensure that all dossier sections contain compliant information which adequately supports your application.

Regardless of whether your dossier needs to be created from raw data (raw materials specifications and monographs, process validation or batch records, finished product specifications and stability data), or your dossier already exists and just requires up-dates, you can be sure our regulatory team has the expertise and experience to find the right solutions for success.