Pivotal study documentation for submission [Regulatives / Guidelines]

posted by Amalia – Greece, 2018-09-24 14:22 (966 d 00:33 ago) – Posting: # 19299
Views: 1,081

Dear all,

as this is my first post I will try to be as elaborate as possible.
Is it possible to send for a pivotal study, not from the validation batches, but from a 100,000 tabs batch prepared in the R&D lab (with GMP accreditation)?
If yes, I guess that it is vital for the specifications of your batch to be the same as the ones from the validation batches (which have not been concluded yet).
What documentation is required in order to link the biobatch with the validation batches?

Thank you in advance,

Amalia

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