What is Regulatory Writing?

Regulatory writing is a specialized field that involves development of preclinical and clinical research procedures compiled from clinical trials, safety reports, and other documents that will help in keeping submission ready documents for the target audience. It is a branch of medical writing wherein the medical writer or the regulatory clinical medical writer focuses on the documents that need submission to the regulatory authorities at various stages of a trial or study.

To launch a new drug on the market, a lot of pre-work is required accompanied by a few obstacles that come on the way before it reaches the target audience. During the journey of drug development, many preclinical and clinical works are required to just ensure the safety and efficacy of the drug before it is launched and utilized by the consumer. Simply doing this preclinical and clinical work in drug development will not ensure the authority to launch the medicine. Like every research done is not completed without communicating its findings to the scientific fraternity, similarly the drug development cycle is incomplete till the developer, manufacturer and researcher communicate about their results to the authorities and register their drug to the governing bodies around the world.

The drug development process needs effective planning and strategy before it is ready for launch in the market, including expectations of the target audience (Patient or the physician). It must go through a thorough evaluation process and then finally to the consumer. All the write-ups should be very precise, must go through a specific process, and in the provided formats. The role of regulatory writer broadens here who must focus on the documents that are required to be submitted to the regulatory authorities at various stages of a clinical trial.

Research and Regulatory Writing

Regulatory writing is an integral part of clinical research. The essential research work done can be utilized in any clinical or drug development process to improve global health. It can enhance understanding of health and diseases, and their management and can improve medical procedures that can benefit the entire society.

Students along with their guide, clinicians, and academic scientists must realize the importance of publishing their research which is not only an ethical and a moral obligation but also a due culmination of the research process. These are the backbone of any medical college, hospital, or university. These publications are helpful for the development of new drugs, which can be further communicated to the global regulatory bodies by filing these in a regulatory department of any healthcare industry. Some clinicians and academic scientists cannot be available to write or submit their research work. The other reasons for not publishing may be inadequate data analysis support, lack of awareness of current reporting guidelines and publication practices, or even inadequate technical writing expertise. All these factors result in a poor quality of writing and can have possibilities of high rejection from established peer-reviewed journals or regulatory authorities. Turacoz provides support to develop these regulatory writing documents and helps in submission of the applications and ready documents for regulatory approval.

Facilities Provided at Turacoz

Turacoz provides support in the development of various regulatory documents such as dossier preparation, product registration for local and export purposes, investigator’s brochure, summary of product characteristics (SmPCs), protocols, case report forms, informed consent forms, clinical summaries, safety narratives, etc.