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PDE Report | Sample Document

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risk assessment

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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Do you Have any Questions?

Talk to our customer advisors

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

Cynthia Schulz

cynthia.schulz@gmp-verlag.de +49 (0)7622 66686-70

Customer Reviews

2 reviews

Average rating of 5 out of 5 stars

100%

0%

0%

0%

0%

Leave a review!

Share your experiences with other customers.

Review with rating of 5 out of 5 stars

Great information

Great information

Mohammed Abdalla Zayed

4 Jul 2022

Review with rating of 5 out of 5 stars

risk assessment

risk assessment

Wei Shao

28 Oct 2020

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