In vitro binding study for sevelamer carbonate for Europe submission [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2023-02-28 18:15 (447 d 17:07 ago) – Posting: # 23481
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Dear Jansari!

❝ we were already given justification based on this sentence.and explain that our study is passing within T/R ratio as per acceptance limit 0.9 to 1.1...but they are not accepting the same and again raised the queries....so now we are repeating the same study ,.


So you are aware about the acceptance limit. Currently what I am able to understand is that you are referring term regulatory for your company's regulatory team and not the authority's team. If it's authority's team- you are already having your answers.

❝ can I have your mail ID ?so I can detailed out the study detail which results we obtained in the study..and what exactly regulatory asked?


You can contact me via contact form in users section but your mail is is not registered, so i am not able to contact you through same medium.
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Regards,
Divyen

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