際際滷shows by User: SachinGundecha / http://www.slideshare.net/images/logo.gif 際際滷shows by User: SachinGundecha / Tue, 22 Apr 2014 05:14:24 GMT 際際滷Share feed for 際際滷shows by User: SachinGundecha Regulatory affairs by sachin gundecha /slideshow/regulatory-affairs-by-sachin-gundecha/33794186 regulatoryaffairsbysachingundecha-140422051424-phpapp02
Drug Regulatory Affairs]]>
Drug Regulatory Affairs]]> Tue, 22 Apr 2014 05:14:24 GMT /slideshow/regulatory-affairs-by-sachin-gundecha/33794186 SachinGundecha@slideshare.net(SachinGundecha) Regulatory affairs by sachin gundecha SachinGundecha Drug Regulatory Affairs <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/regulatoryaffairsbysachingundecha-140422051424-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Drug Regulatory Affairs
Regulatory affairs by sachin gundecha from Sachin Gundecha
]]> 1470 3 https://cdn.slidesharecdn.com/ss_thumbnails/regulatoryaffairsbysachingundecha-140422051424-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://cdn.slidesharecdn.com/profile-photo-SachinGundecha-48x48.jpg?cb=1686653860 Worked for USA (ANDA). Review and compilation of ANDA, WHO dossier. CMC Writing/Annual Report preparation/CBE 30 Filing/Amendments. WHO pre-qualification dossier. Worked for ROW market, for Asia and Africa. Compiled ACTD, CTD, and Other country specific formats. Filed marketing authorization to TFDA, KFDA,PRA in CTD formats. Handling query and technical issues of the products. Providing regulatory support to the company in order to obtain marketing authorization for commercial products. Strong regulatory background includes knowledge of international registration guidelines & regulations. The work profile also includes the review of various master documents.