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PDE Report - Sample Document

Are you not quite sure what a PDE report looks like and would like to take a look inside? Get your free sample document now!


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Are you not quite sure what a PDE report looks like and would like to take a look inside? Get your free sample document now! 

Why do you need a PDE report?

As of June 1st 2016, health based exposure limits have to be determined for all APIs of human and veterinary medicinal products produced in multi-purpose facilities.
>>> More information

Our service includes

1. Issuing of the PDE report

  • according to EMA guideline in English
  • issued on your company name according to EMA guideline requirements
  • issued by European toxicological experts

2. Brief explanation/training of the report (10-15 min) in English by a toxicologist after delivery of the report (via Skype)

This is what we need from you to prepare a quote

  • Company name and address
  • Name of the API
  • Dosage form
  • Route of application of the API or of the potential next product that is produced in the same facility (cleaning validation)


If you have questions or would like to request a quote, please contact:

Cynthia Schulz
Phone: +49 7622 6668670

or request your quote now!

>>> Read more about PDE reports

Are you also interested in OEL categorisations and elemental impurities risk assessments?
>>> Read more about OEL categorisations
>>> Read more about elemental impurities risk assessments

Von Mohammed Abdalla Zayed Am 04.07.2022

Great information

Great information

Von Wei Shao Am 28.10.2020

risk assessment

risk assessment

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Please note the following procedure guidelines:

For payment by invoice:

  • You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
  • After receipt of payment you will receive an e-mail with the download information.

When paying by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • Your invoice will be sent in a separate e-mail within 1-2 working days.


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