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Q&A with Quality RA

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, and your question might be selected and answered on our website.

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


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

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