Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities. https://www.cognibrain.com/regulatory-medical-writing/

1. What is Regulatory
Medical Writing?
Regulatory medical writing is an integral part of
Medical Communications but is often overlooked. In
simple terms, it involves writing the documents
required for the approval of drugs by the regulatory
authorities.
The regulatory authorities like FDA, Health Canada,
European Medicines Agency, and others assess the
efficacy and safety of the drugs through all phases of
their clinical trial and ultimately approve their use in
patients.
Regulatory writing helps these authorities in doing so
by preparing a variety of clinical documents. Starting
with the description and reporting of the data from
clinical trials, it prepares regulatory submission
documents and produces post-approval reports on
the use of the treatment in patients.
Thus, a regulatory medical writer has to prepare a
whole range of documents like Investigator’s
Brochures, Clinical Protocols, Patient Information
Sheets, and Clinical Study Reports.
While preparing such documents, he needs to work
closely with study Clinicians, Statisticians, and Chief
Investigators. He must understand the Good Clinical
Practice (GCP) observed in clinical trials and publish
the documents in accordance with the guidelines set
by these regulatory authorities.
SOURCE
HTTPS://WWW.COGNIBRAIN.COM/REGULATORY-MEDICAL-WRITING/