Whitepaper: Diffferences between CTD Brazil and UE: a look at CMC requirements
Our daily lives at Vita are full of discussions about technical and regulatory differences in the regions in which we operate, since we work with dossiers to be submitted in different regions. With the implementation of the CTD in Brazil, these internal discussions have increased even more.
Hence the idea came up, through a whitepaper, to share with the professionals who follow us, customers and partners who also contribute a lot to us, a look at some main differences in the issues of module 3 of CTD Brazil and EU.
But after all, what is a whitepaper?
It is nothing more than a material with more in-depth content on a given subject. Warning: it is not a scientific article.
We then prepared this material with great care and dedication, aiming to point out some of the differences in CTD Brazil and CTD UE, regarding module 3, the quality module, also known as CMC (Chemistry, Manufactruing and Control).
We hope that this whitepaper will be useful to you.
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