Regulatory Submissions: Paper vs. Electronic

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I recently attended a Pharma Regulatory Writer’s Conference in Baltimore, and I have to say that I was truly surprised by the number of companies still submitting their regulatory submissions in paper format.

The migration from what is still a manually driven, physically intensive process to a simplified automated task may seem daunting, but in reality, half the battle is already won. Applications are no longer written and transcribed by typewriters; they’re created electronically with word processing software. Electronic compilation with applicable submission software versus manual collation further expedites the process. The added cost and time delays required by man-hours to print and assemble dossiers adds even more time to process your submission, in turn delaying the approval process.

With the pending 2014 FDA mandate for electronic submissions, it’s wise to invest in a system that will greatly increase operational productivity and further ensure your submissions are technically sound and error-free. The reduced labor costs saved would easily validate the budget associated with the implementation of a software solution. Your return on investment would be realized quickly as your applications would be approved sooner; therefore maximizing your product’s profitability and your company’s bottom line.

To learn more about the eCTD mandate click here. For more on making the transition from paper to eCTD click here.

Author: Shawn Nicholas

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