Introduction
It now takes roughly $2.5 billion and more than 10 years to bring a new drug to market1. Over the course of that journey, biopharma companies face many obstacles and risks including managing their ongoing interactions with regulatory agencies.
与监管部门沟通开始s soon as researchers identify a potential use for a new drug or device. From that point on, every interaction with an agency is critical and, in some regions, must be documented and made available during any inspections.
If an agency requests specific information or action, that request becomes a commitment that the company must complete and document. Effective interaction plays a vital role in initial market approval and is mandated to continue throughout the product’s lifecycle to maintain compliance.
With the increasing numbers of products across a growing number of markets against a backdrop of diverse, changing requirements, the regulatory complexity for a company can be mind-boggling.
The required level of compliance is best supported when organizations have a regulatory information management (RIM) system in place that can capture compliance-related data from multiple business units and organize it for easy access and review. However, lacking this level of regulatory data management sophistication, many companies are putting themselves at risk.