You already have a Pre-IND number (PIND)? If so, please use that number and additionally, obtain drug facility registration number (since you said that drug is manufactured in a GMP facility so your facility must have been registered already) and prepare an end user letter and give it to your custom import broker. If you need help including dealing with the FDA compliance at port of entry if detained, contact us.
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GRSAOnline
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Original Message:
Sent: 22-Nov-2018 11:33
From: RAMGOPAL NADIMPALLI
Subject: Clinical drug substance shipment
Hello All,
We manufactured GMP drug substance in Europe and we will need to ship it to the US for final GMP drug product manufacture for clinic. I have two questions if anyone can please respond to.
1. We do not have an IND# yet but have pre-IND#. Can we use pre-IND# to ship this bulk GMP Drug substance to the US or need IND# to do that? Which means, do we need to wait until we have an IND# for shipping the package? My understanding is that we need an IND# but need some expert opinion on this.
2. Without an IND#, is there a way that we can seek an exemption to ship the package? Even if we can ship with such exemption (if it exists). should we wait to fill it until we get the IND#?
I would appreciate if anyone can respond and share their thoughts. Thank you in advance.
Gopal