The current global scenario recognizes regulatory medical writing as a tool to for developing authenticated documents related to products undergoing clinical trial. The purpose of regulatory medical writing is to offer the highest quality scientific documents for fulfilling the requirements of particular audience. Regulatory medical writing has grown complex with the introduction of new requirements for drug approval.
The writers who prepare these documents are called as “regulatory medical writers” who keep themselves up to date with the current regulatory needs and explore medical writing in the regulatory domain from various angles. Medical writers also work on several other documents of any clinical research development like statistical analysis plans [SAPs], summarising of highly complex data, and are core part of the team. Regulatory medical writing is an essential part of the clinical research process. The regulatory medical writer should have thorough understanding of the data for correct interpretation besides having the capability to sum up the statistical results.
While offering regulatory medical writing, regulatory writers must be well versed with all the relevant guidelines like International Conference on Harmonization (ICH) guidelines, European Medicines Agency scientific guideline and many other relevant information. Clinical data management, biostatistics, medical affairs, and scientific writing fall under the purview of regulatory medical writing. During protocol development, regulatory medical writer, are not only involved with the internal team but also with the sponsor to build up a protocol that is easily executed in the clinical setting. When the protocol is applied at the clinical site, the regulatory medical writer continues to be part of the process.
Regulatory medical writing involves the continuous process of reviewing the Statistical Analysis Plan (SAP) and finally developing a clinical study report (CSR). Regulatory medical writers are involved in the reassessment of blinded listings to ensure data quality and integrity before database lock. The outcome of every CSR finally turns out to be a part of the drug submission documentation i.e. called New Drug Application (NDA).
It is a major challenge for Pharmaceutical industries and Clinical research organizations to identify processes for speedy submission of information to the appropriate regulatory agency when needed. Only expert regulatory medical writers recognize the requirements and expectations of the regulatory agencies. Regulatory medical writers are open to a range of tasks and can suggest insight in protocol design so that the data obtained from the clinical trial will reflect the proposed information required for product labelling, data interpretations, provide summaries of extremely complex data, and present suggestions for process improvements to clients.
In any pharmaceutical industry, medical writers specialize in and have primary responsibility for documents in specific areas viz. CMC (Chemistry, Manufacturing and Controls) of a drug, nonclinical, or clinical. Regulatory medical writer form an integral part in development of any drug right from protocol to drug approval process. Regulatory medical writing provides the highest quality scientific documents with the proper data management and with full quality and safety of clinical data for its approval. Hence pharmaceutical organizations are hiring expert medical writers having sound knowledge in regulatory affairs.
WorkSure® regulatory writing team provides complete support in preparing dossiers and application for IND, NDA and CTA. We have particular therapy area expert who help in preparing protocols for all phases of clinical trials. We also have expertise in developing investigator brochure, ethics committee documents and other trial related documents. Our team can also deliver 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.