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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.

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Medical Affairs has originally emerged as a reaction because of increasing pressure from regulators to separate medical and commercial functions. Companies have been experiencing increasing internal demand to focus on generation and development of new products rather than managing products after FDA approval.

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.