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The current global scenario recognizes regulatory medical writing as a tool to for developing authenticated documents related to products undergoing clinical trial. The purpose of regulatory medical writing is to offer the highest quality scientific documents for fulfilling the requirements of particular audience.

Medical Affairs team works closely with the clinical development team for planning and organizing clinical development plan, protocol development, investigator selection and meetings, ongoing data maintenance and management, statistical analysis & interpretation, report writing activities etc. They are involved in pharmacovigilance, regulatory support, post marketing safety and surveillance studies.

Medical writing is the process of writing scientific or regulatory document by specialized writers known as the "medical writers". Medical writers might not be the real scientists who did the authentic research, but work with the physicians / scientists concerned in the creation of data, and thereby assist to present that data in appropriate and clear way.

Medical writing conveys clinical findings from research labs to the masses in form of articles for publication, regulatory documents, and content development for pharma-healthcare magazines, newsletters and websites. The criteria of writing the medical content mainly depends upon the need of the end users for examples documents for the medical journals, physicians, healthcare organisations, pharmaceutical companies, etc.

Biomedical researches, conducted by various organizations are required to be documented in accordance with regulatory and public requirements. Medical writing is a specialized technical writing that generates explicit documents as per standard operating procedures to suit target audience.

As soon as a potential moiety is identified it is subjected to pre-clinical studies for determination of safety, efficacy, pharmacokinetic and pharmacodynamic profiles of molecule which are later extrapolated to human volunteers or clinical subjects under clinical research. Clinical research is carried out meticulously at academic blocks, healthcare organizations and research study centers affiliated by regulatory bodies.