Surviving The Paperwork: Why Seamless Submissions And Good Compliance Envelopes Matter

By Alok Tayi

Are you finding it increasingly challenging to manage your organization’s regulatory submission process? The entire process of developing a drug from preclinical research to marketing takes approximately 12 to 18 years and can cost billions of dollars before a drug is even approved. I recently had a pharmaceutical R&D executive tell me their organization’s most recently FDA-approved drug submission was over 950,000 pages; stacked up, that’s the equivalent of 310 feet or the height of the Statue of Liberty. 

Take that in. Think about how much valuable and critical data resides in that stack of paper.