Regulatory Medical Decision Making

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Medical writing is the science (and art) of communicating health and health care related information to various stakeholders. Regulatory medical writing means developing the clinical documents those regulatory agencies need in the approval process (IND, NDA and ANDA submissions) for drugs, biological and biosimilars. Regulatory medical writing involves writing scientific documents of different types which includes protocol, informed consent form, clinical study report, investigator brochure, common technical documents, safety and efficacy summaries, etc. It is the activity of creating complex scientific data in a perfect and succinct way for different stakeholders and target audience. This field helps to bring clinical documents to the pharmaceutical
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