Welcome to our ‘Q&A with Quality RA’ series. 

In this section we provide answers to questions we are often asked. We will add topics on a regular basis.
If you have questions, you can send them to info@qualityra.nl, and your question might be selected and answered on our website.

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Another option is to book a live ‘Q&A with Quality RA’ session. In a live session you can ask us questions on RA and CMC topics. For example, RA topics: regulatory procedures, scientific advice, regulatory submissions, etc. Examples of CMC topics: stability studies, development, qualification/validation and transfer of assays, reference standards, how to present CMC information in regulatory dossiers throughout the product lifecycle, etc. 

 

We will either schedule an on-line or live meeting for this session, depending on the location. This opportunity is being offered for an introductory fee. For more information, please contact us at info@qualityra.nl


Topics:

- ICH Q2(R2) and ICH Q14: What's new? | 09-01-2024