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PDE Report - Sample Document

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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!

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Technical Requirements

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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)

Questions?

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

Cynthia Schulz
Phone: +49 7622 6668670
E-Mail: cynthia.schulz@gmp-verlag.de

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

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