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CMBarnett Pharma Services Ltd 2008-2011

Due Diligence Back Home

Manufacturing processes

  • Do they comply with regulatory expectations for the product type?
  • Are they in accordance with the dossier?
  • Are they validated?
  • Is the inventory as listed and of the value stated?
  • Does it tie up with the commercial forecasts?

Laboratories

  • Are they equipped, staffed, and operated in accordance with regulatory standards?
  • Does the product routinely comply with the registered specifications?
  • Are the test methods validated?
  • What stability data is there?
  • Will you need more?

This is not an exhaustive list of topics, but it gives you some idea of the issues that you need to cover as part of your valuation of a product.