The registration of products containing established drug substances and previously-approved (generic) drug products presents unique challenges for regulatory departments worldwide. Not only are there different systems for the registration of true generics (look-alike) compared with products containing well-established, off-patent substances, both of these systems vary according to the specific requirements of regulatory agencies around the world.
Because Kendle has an in-depth understanding of what is needed to register an established drug substance, we can provide a fast, streamlined submissions service with full publishing capability for paper and electronic submissions, including electronic Common Technical Documents (eCTDs).
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Click here to download our Established drug substances factsheet