Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Dossier robustness

Having clearly stated the importance of understanding the science behind the product, BioVentures Consulting Limited prefers to get ‘right into the detail’ of the product and its development history.

It is only through a detailed understanding of the science….that robust responses can be made

BioVentures Consulting Limited’s preferred policy is to work with our client company to understand the product and its development issues ‘inside out’ – for example:

  • the assay development
  • product specifications (and how these may vary in different regions)
  • validation methodologies, production ingredients
  • clinical end-point selection
  • dose level rationale
  • patient inclusion criteria

and so on.

It is only through a detailed understanding of the science and of the technologies applied that robust responses can be made to regulatory agencies following product assessment, review and opinion. BioVentures Consulting Limited is able to advise on dossier quality and dossier robustness by assessing issues such as:

  • stability data
  • manufacturing process validation
  • whether impurity profiling has been adequately detailed or not
  • and whether specifications have been adequately justified
  • batch-to-batch consistency
  • whether the control of drug substance and drug product are adequate.
  • a review of the adequacy of manufacturing process documentation and potential GMP compliance issues.

For more information contact us on: This email address is being protected from spambots. You need JavaScript enabled to view it.

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