For life science companies, the pressure lies not only in developing an innovative drug or medical device but in beating the competition to market. It is not enough to spend millions of dollars in product development, it is equally critical to be the first to market the new product. Timely product launch is greatly affected by compliance - the purview of the regulatory affairs team. In light of intense competition in the global market, life science companies are increasingly relying on regulatory affairs software to support their compliance efforts.
In life science companies, the regulatory affairs team is considered the "quarterback" because it is the leader in terms of compliance efforts. It is responsible for regulatory submissions and global marketing approvals. Just like a quarterback, the regulatory affairs team coordinates all other departments that have a bearing on product approval and compliance. So how can regulatory affairs software help your quarterback?
The regulatory affairs team is typically the primary group that communicates with the appropriate regulatory body (e.g., the Food and Drug Administration in the United States or the European Medicines Agency in the European Union). The more markets the company wants to enter, the more regulations and standards it must comply with, making an electronic regulatory affairs system indispensable.
Many companies still use paper-based document management systems, but bigger companies and other organizations that are keen on competing globally (regardless of their size) are likely to use regulatory affairs software. An electronic regulatory affairs system can help standardize and streamline the essential functions of a regulatory affairs team, including coordinating and managing regulatory submissions with the R&D, quality, manufacturing, clinical research, and other teams. This includes submissions for a new product (e.g., investigational new drug and new drug applications to the FDA in the United States) or marketing authorization applications (in Europe and other parts of the world).
After the product has been launched in the market, the use of regulatory affairs software can greatly speed up the preparation and submission of post-marketing reports to various regulatory bodies.
MasterControl quality and compliance software is designed to help you comply with the most rigorous regulations and standards that exist today. It automates, streamlines, and connects all processes critical to compliance, including document management, training control, CAPA, audit management, and change control. The following features make it an effective foundation for your regulatory affairs system:
For more information about MasterControl's regulatory affairs software system Contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.