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An IS0 9001:2015 Certified Institute

Medical writing

Changing market dynamics, expiring patents, and depleted product pipelines are all exerting pressure on pharmaceutical companies to outsource non-core activities in an effort to control costs and enhance drug-development cycle time. One of these activities is medical writing—an area that, although not at the core of pharmaceutical operations, has become increasingly critical as regulatory agencies have adopted more elaborate review measures that require substantial amounts of documentation.

Medical writing involves creating well-structured scientific documents that include clinical research documents, content for healthcare websites, health magazines, journals, and news. Medical writing can be classified into two types: Regulatory medical writing and Educational medical writing.

Regulatory medical writing involves writing documents for regulatory agencies seeking approval for devices, drugs, and biologics. This includes clinical trial data, regulatory submission documents, post-approval documents, etc.

Educational medical writing is writing documents about devices, biologics, and medicine, specifically for general studies

Our work expertise

Through vast knowledge in medical writing, our team of medical writing experts involves in the following activities, we keep the best effort to provide precise data and easily regulatory approvable

  • Submission modules (CTD Sections 2.4, 2.5, 2.6, 2.7, 4 and 5)
  • SUSARs, PSURs / PBRERs and DSURs including medical review
  • Risk Management Plan (RMP)