The next big market share grab will go to the organization that figures out how to reduce the number of resubmissions to the Food and Drug Administration (FDA) , and thus reduce the time it takes to get a product to market.

When you have a project on a large scale such as the development of a new drug, there may be several teams, each with a different manager working in parallel on any of the hundreds of working pieces that make up a New Drug Application (NDA) submission. With an increased number of hands on any given project, there is bound to be redundancy, overlap or overlooked components, right?

Take, for example, (pick a different small scale example) planning a wedding. Working with a (usually nonnegotiable) deadline and a limited budget (for most), one must not only try to convey their “dream wedding” as they envision it to reality, but must also coordinate with possibly dozens of vendors, who all need to provide their given services in a certain order and/or timeframe in order for the “dream to come true.” On top of adherence to your schedule, each vendor has other customers to whom they must provide services. Aside from the dizzying level of logistical mayhem which is to ensue, you also have the nearly inevitable human error and miscommunication resulting in last minute hair pulling.

While in this example, the financial result could potentially cost several thousand dollars, in the pharmaceutical industry, a poorly managed NDA project where a resubmission will set you back years, and the resulting rework could cost the company and its investors an overrun in the hundreds of millions.

A resubmission to the FDA can be for the slightest of omissions. You need a better way to track every step of the process – and not only during the Clinical phase. You want to start at the beginning during the ideation and initiation of a new drug to ensure everything is captured and transferred correctly.

Just imagine a project environment where every moving piece could be tracked and all required tasks are assigned with a level of detail and precision that would result in the elimination of resubmissions and rework due to human error or miscommunications entirely. An environment where there is no unnecessary redundancy or overlap in work performed and the managers could focus their attention and energy toward ensuring – I don’t know – that the lab animals behave. In this sort of environment, you could even produce reports to stakeholders that show the project is actually ahead of schedule. Too good to be true? We don’t think so

Contact us to learn more about how to reduce the number of resubmissions to the FDA.