PDE Report | Sample Document

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Great information

Mohammed Abdalla Zayed

4 Jul 2022

Review with rating of 5 out of 5 stars

risk assessment

Wei Shao

28 Oct 2020

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Why do you need a PDE report?

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

Our service includes

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

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 produced in the same facility (for cleaning validation)

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Cynthia Schulz, Vertrieb und Key Account für Toxkologische Gutachten beim GMP-Verlag

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Do you have any questions about our products and services? We are here to help.

Cynthia Schulz

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Customer Reviews

2 reviews

Average rating of 5 out of 5 stars

Leave a review!

Share your experiences with other customers.

Login

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Display reviews in current language only.

Review with rating of 5 out of 5 stars

Great information

Mohammed Abdalla Zayed

4 Jul 2022

Review with rating of 5 out of 5 stars

risk assessment

Wei Shao

28 Oct 2020

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