While finding the right publishing vendor provides tremendous value to an organization short on internal resources, it is important to be thinking beyond eCTD publishing. Pairing with a vendor that can offer extensive regulatory and communications strategy, science and solutions experience brings numerous synergies.
Optimizing Regulatory information management (RIM) is something every pharmaceutical company must plan for. Defining RIM can be a challenge, however, since there’s no ICH standard for what should be done. But right now your organization is dealing with the reality of managing several drug submissions weekly for multiple medicinal products. That includes keeping track of the regulatory activities associated with these submissions, attempting to manage agency commitments, and organizing and sharing the daily updates of agency correspondence. Without a central hub to capture critical regulatory data and turn that data into actionable intelligence, your business is at risk of missed deadlines, delayed market approval, and non-compliance.