Khushi Soni
Medical Writer - Clinical Trials at Cliantha Research Limited
Based in Ahmedabad, India
7-day free trial · no credit card
Seniority
Other
Department
Other
Location
Ahmedabad
Industry
Research Services
Company size
1.7K
Contact information
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k•••••••@cliantha.com
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5 credits+91 ••• •••• ••••
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Background
About Khushi Soni
With the background of PHARM D and experience as a Clinical Research Coordinator, currently I am working at Unison Pharmaceuticals with the Job responsibilities of :Preparation, Review and Finalization of documents for CTD Module 2.4, 2.5, 4.3 and 5.4 ( Clinical overview, Nonclinical overview) and Summary of Product Characteristics (SmPC) in compliance with applicable regulatory requirements. Provide justification for the Biowaiver applications. Preparation of Scientific advice documents which are requested from Regulatory body (CHMP) before initiating clinical trial.Support for biopharmaceutical aspects for ongoing projects and also resolve Regulatory Queries from clinical point of view.Execute Post marketing studies and PSUR related activities for support of the domestic market. Support ongoing BA-BE study.
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