If a pharmaceutical company delays in completing or discontinuing a clinical trial of its drug candidates, the commercial prospects of the drug candidates will be harmed and the ability to generate revenue from any of these drug candidates will be delayed.
#DOSSIER DEFINITION IN PHARMA REGISTRATION#
R&D – Clinical phase: setting up the right Clinical Development StrategyĮarly in the development process, at the research stage, it is critical to get regulatory affairs involved to ensure that an appropriate Clinical Development Strategy is developed with the goal of a carefully planned series of clinical trials, ranging from first-in-human Phase I to Phase II “proof of concept” and crucial Phase III trials for registration purposes.Ĭlinical trials are expensive and can take many years to complete, and their outcome to demonstrate the drug candidate’s efficacy is inherently uncertain. Sounds familiar? This post will give you a better understanding of the role of Regulatory Affairs in the pharmaceutical industry at large and the functions that Regulatory Affairs teams can provide in the lifecycle management of your pharmaceutical product. Experienced consultants to ensure all filing and submission goals are met, with high quality and within expected timelines.
Many pharmaceutical companies are looking for external RA team members with specific expertise to ensure that products are developed, manufactured, and controlled at all levels of expected quality, safety, and efficacy.
In this way, they make a significant contribution, both commercially and scientifically, to the success of a development program and the company as a whole. The Regulatory Affairs department provides strategic and technical advice at the highest level in such companies. They possess a unique combination of both scientific and management skills to achieve a commercially important goal within a drug development organization. Regulatory Affairs experts are involved in all phases of development, and even after drug approval and commercialization. Regulatory Affairs plays a crucial role in the pharmaceutical industry, especially during drug development: a lengthy, complex, and extremely costly but necessary process.
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