Drug development is a complex process that involves many steps and procedures. According to an assistant professor of regulatory affairs, it typically takes over ten years for a single drug to reach the market. This process requires collaboration among various groups within an organization. Cross-functional groups such as R&D, manufacturing, quality assurance, and sales are often needed to advance a drug’s initial development to its eventual sale.
Every step of the drug development process involves demonstrating the safety and efficacy of the drug. This process is carried out by submitting detailed data to external health authorities and regulatory affairs departments.
What Is A Regulatory Submission?
FDA Submission support is a set of documents that a drug company submits to a health authority for review. It serves as proof that the company is following proper procedures and that it is following the requirements of the law. The documents also contain important details about the development of the drug.
The process of filing a regulatory submission usually begins in the early stages of developing an investigational drug. These documents are used throughout the entire clinical development process. The regulatory submissions required to get approval for a drug include the New Drug Application and the Investigational New Drug Application.
Investigational New Drug Applications (IND)
The initial IND allows a drug company to start the clinical research phase. The documents submitted for this process can contain over 10,000 pages of information. They also include various reports and other documents related to the drug’s development.
Throughout a drug’s life, various amendments are made to the documents to improve the quality of the product. Some of these amendments include the creation of a protocol amendment, an information amendment, or an FDA submission support. In addition, other functions such as the publication of an annual report or an updated investigator’s brochure are also carried out.
During a clinical study, a company may also make numerous amendments to the documents to improve the safety and efficacy of the drug. These amendments are usually submitted for a single compound studied for its potential use in treating or diagnosing a specific condition.
New Drug Applications (NDA)
The initial NDA is a set of documents that a drug company submits to a health authority for review. It allows a company to market and distributes its product. This document type is similar to the IND in that it contains various information. It also includes administrative reports, clinical study reports, and manufacturing information.
A drug must be approved by the health authority to remain on the market. To ensure that the product remains on the shelves, many companies use the services of regulatory affairs professionals, who can maintain the approved NDAs. These professionals perform various tasks such as reviewing safety reports, issuing new indications, and manufacturing process changes.
Filing an IND and maintaining the approved NDA are two of the most important steps in an FDA submission support. They help a company to bring potentially life-saving medicine to market. In addition to maintaining the documents, timely submission of an NDA allows a company to get the necessary data to the health authority.