Challenges In Managing Life Science Regulatory Submissions & Correspondence

By Ed Miseta, Chief Editor, Clinical Leader

Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

“Once you’ve made that submission, what will happen next is a lot of back and forth with the regulatory authorities,” says Lori McKellar, Director of Marketing for Life Sciences at EMC-IIG. “There will be questions, requests for clarifications, and requests for additional information, just to name a few. That ongoing conversation will involve emails, phone calls, and meetings (with minutes). Although all of that information is now associated with this particular submission, it is sitting on multiple systems within the organization.”