Regulatory due diligence considerations

Due diligence

  • available licenses and their validity
  • availability and validity of CE and ISO certificates for medical devices
  • supporting Good Manufacturing Practice (GMP), manufacturing and other certificates
  • status of the regulatory documentation including the quality of dossiers or technical files
  • Warning Letters and any compliance issues
  • status of patents and their expiry dates
  • status of trade names and their expiry dates

The status of technical files and dossiers need special attention. Very old files with obsolete formats or standards may require complete reformatting or updating. Especially with very old files, vital information could be missing. Updating such information could be a very costly endeavor for the acquiring company.

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The Marketing Authorisation Holder (MAH) has ultimate responsibility for all its medicinal products marketed within the EU (1).  We see the results of inadequate Due Diligence on a regular basis, finding, often at a late stage that the acquired dossier:

  • Is incomplete!
  • Is out of step with current guidelines!
  • And/or there is no consistent record of what has been submitted to Health Authorities!

Penalties imposed by regulatory authorities on companies failing to ensure regulatory compliance have included fines, withdrawal of an MA, product recalls or disruption to product distribution at a regional level. – graph, some statistics ..


Review of the Registration Dossier

For dossiers before registration and for products already commercialised, a review would aim to indentify and record:

  • Dossier completeness
  • Any formatting  issues (electronic, CTD)
  • Compliance with current EU guidelines / legislation
  • On-going regulatory issues (pending variations,)
  • Any outstanding regulatory commitments (eg stability data)
  • Compliance of Product Information (PI)
  • Regulatory actions required

Results can be presented in a report format and / or Registered Technical Details (RTDs) can be generated for the product as necessary.


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