Monday, 28 September 2015

Regulatory Medical writers A Document Focused Scientific experts


Medical writer plays an important role in providing information to the targeted audience.  Regulatory medical writing involves regulatory documents that are required before the approval of drug. All new drug or chemical entity undergoes many level of test for its purity, safety and efficacy. These include clinical study protocol, clinical study report, patient consent form, summary document (common technical document).  It is an internationally agreed format for the preparation of applications regarding new drugs. It was developed by EMA, Europe (European medical agency), FDA (Food and Drug Administration), MHLW, Japan (Ministry of Health and Labour Welfare). The CTD is maintained by ICH (International Conference of Harmonisation). The regulatory documents required are INDA (Investigational New Drug Application), NDA (New Drug Application), and ANDA (Abbreviated New Drug Application. The regulatory writer prepares the document to be reviewed by FDA and for further proceeding with the clinical trials. The strength of medical writer depends on its experience and ability to understand well the regulation requirement by the corresponding agengies. Other regulatory documents like Product Monograph, Full Prescribing Information, Patient Information Leaflet, Summaries of Product Characteristics (SPCs), Risk Evaluation and Mitigation Strategies (REMS) etc. for both drugs and devices also be a part of regulatory document. The drug safety, quality, strength and purity is assured by NDA to permit FDA for final submission.
The regulatory medical writer is an expert and more specific than any other writer as they have to deals with the regulations in ICH which involves application submission, withdrawal and termination of particular drug. The regulatory medical writing team also involved in preparing dossier, protocols for all clinical trial phases and application for INA, NDA, CTA.  As the detailed study of the drug is to be compiled and documented, the writer must know about the statistical analytical processes (SAP). They must be having good knowledge about the new regulations and amendments in ICH. In pharmaceutical organisation and clinical research organisation, the writer must be active to submit the information to the regulatory agency when needed. The medical writer has the primary responsibility for documentation of the specific areas such as CMC (Chemistry Manufacturing Control), clinical and non-clinical. After the protocol development at the clinical sites, the regulatory medical writer review SAP, followed by clinical study report. The writer has ability to complete and concise CSR that shows the result of clinical trials. Finally the results of each CSR are to be submitted to the regulatory authority. This procedure from developing protocol to the submission of document is undertaken by regulatory medical writer. The work of regulatory medical writer is wide-ranging. They have to face many challenges in pharmaceutical and clinical research organisation. As an individual they have to look into the protocol design in order to produce proper data out of the clinical trials necessary for labelling of product, support in data analysis, and summarises the complicated data. Additionally, Regulatory medical writer is always anticipated in the query resolution and for advancement to the sponsors.

We at WorkSureTM have a specialized team of regulatory medical writer. We deal with all type of regulatory document IND, NDA and CTD. We are also involved in generating protocols for all phases of clinical trials. We have the capability to work for regulatory agencies of various countries including USA, Canada, Europe, Japan, India etc.


  1. Nice Information
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  2. Thanks for nice information
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