Paper Contents
Abstract
Regulatory affairs refers to a profession or department within industries such as pharmaceuticals, medical devices, biotechnology, and other sectors regulated by government agencies. This field involves ensuring that companies comply with all the regulations and laws pertaining to their business, particularly in the development, manufacturing, and marketing of products. The goal of regulatory affairs is to protect public health by ensuring that products are safe, effective, and meet all necessary standards set by regulatory bodies like the FDA in the United States. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. . Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers .The regulatory procedure through which an individual, organization, sponsor, or innovator obtains approval to introduce a drug to the market is referred to as the approval process. This process involves the submission of technical documentation to the relevant authority.Key Words: Regulatory affairs; Regulatory Agencies; FDA; eCTD; Regulatory market
Copyright
Copyright © 2024 R.Kabilan. This is an open access article distributed under the Creative Commons Attribution License.
