Chemistry, Manufacturing and Controls (CMC) for
IND, CTA, NDA, ANDA, MAA Applications
Chemistry, Manufacturing and Controls (CMC) for
IND, CTA, NDA, ANDA, MAA Applications
We provide comprehensive support in authoring full CMC sections, partial CTD modules, or conducting expert reviews to identify potential regulatory deficiencies.
We support change control assessment, and global lifecycle management submissions including USA & EU.
Let's connect & Collaborate with your post approval applications.
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