My experience is for biologics, but I would expect it to be similar. I plan approximately 3 months for authoring/submission (includes 1 week for publishing). However, this is flexible – often some info gets dropped in during the last month of authoring, right before final review and publishing. At a minimum, I would expect it to take 2 months after the tox report is available (although heroic measures are always possible).
Catherine M Anderson, PhD, RAC
Senior Manager, Regulatory Affairs CMC
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
firstname.lastname@example.org+1 301 770 2920
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