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MR Indraneel Dasari, RAC

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RE: Experience transitioning between Reg Ops and Affairs?

Posted By Indraneel Dasari 13-Feb-2018 20:27
Found In Egroup: Regulatory Open Forum \ view thread
Transitioning between regulatory ops and affairs requires a different expertise. With respect to Regulatory operations, your expectations would be deliver dossiers by consolidating the scientific database and delivering it within stipulated timelines which your organisation would have targeted. ...

Request for info

Posted By Indraneel Dasari 13-Feb-2018 15:17
Found In Egroup: Regulatory Open Forum \ view thread
Can anyone let me know if there are any guidelines for proposing a shelf life for a combi pack ( One secondary pack containing Drug Product and diluent) if the stability data supporting shelf life is more for Drug product when compared with Diluent. Regards, Indraneel D ------------------------------ ...