Regulatory Approval Systems
Technology has the power to significantly enhance the efficiency and accuracy of regulatory approval processes.
Navigating and managing the internal regulatory approval process is often one of the most time consuming and challenging aspects of a brand team’s operations. Many pharmaceutical manufacturers are still employing partial or full paper-based approaches for their regulatory approvals. While internal MLR submission, review, and tracking of promotional material may always be somewhat of a frustrating task, paper-based operations tend to make this process far more arduous than it necessarily needs to be.
Technology has the power to significantly enhance the efficiency and accuracy of regulatory approval processes, not only increasing speed, but also enhancing user experience. While initial investment in building the system is required, this cost is quickly recouped in future efficiencies and elimination of time-consuming efforts associated with the old system. The positive environmental implications of a paper-free system are a clear benefit as well.
Katalyst has helped several of our pharmaceutical clients and regulatory bodies take traditional paper-based approval processes and convert these into highly functional online systems.
Working with our client partners, Katalyst begins this process by defining the goals and objectives of the initiative. Typically this strategy involves maximizing efficiencies and speed of approvals, while also enhancing team communications, documentation and reporting.
An early step also involves stakeholder interviews with both the reviewers and the users of the system (brand team, agency partners, admin assistants, etc.). This step helps our team fully understand the needs and expectations of the end user. Requesting user input at the outset and throughout the build will not only ensure the end solution meets the needs of the user, but it will also help maximize uptake and adherence to the new system at launch.
How We’re Different
|“Off-the-shelf” software||Custom solution|
|Lack of platform flexibility||Highly flexible architecture|
|Limited user input opportunities||User informs solution throughout|