I am currently working on authoring the CMC sections of a new BLA which my company is planning to file later this year. Some of the submission planning tools which have proved to be very productive in tracking this beast of a submission are as follows:
1) Veeva: I have worked on a couple of QMS systems before but this is the most robust QMS I have used. Very user-friendly and super convenient in searching documents, checking-out, and checking-in docs, sending docs for reviewing or authoring and sending reminders to the reviewers about their due date. 2) Smartsheet: This is something new which was introduced in our company and this is 1000 times better than any other project management software I have ever used. You can generate reports and update tasks in a very lucid and simple manner. Since I was involved in the project management of this submission for a while, I can definitely vouch for this software to make your life a lot easier. 3) PleaseReview: This has made the review of documents very convenient as it helps to keep accountability and clear visibility for all the review comments. Combining PleaseReview as a function in Veeva has made the review process much more transparent and clear.
Hope this was helpful.
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