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| WorkSure |
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.