Monday, 5 October 2015

Excellence in regulatory documentation rendered by medical writer

Regulatory Medical writing is an activity of writing scientific documents which are pivotal for the approval of any new drug or device. A team of specialized medical writers are involved in the preparation of Investigational Medicinal Product Dossier (IMPD), Clinical Trial Application (CTA), Common Technical Document (CTD), Investigational New Drug (IND) & New Drug Application (NDA). The regulatory medical writers must have the good knowledge of new and changing global regulations and ICH guidelines to meet the requirement of sponsor. At WorkSureTM we have the capability to work for regulatory framework of various countries including USA, Canada, Europe, Japan, India etc.

4 comments:

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