CMC Documentation

In order to launch your drug on the market or start the clinical studies, you’ll need a package of GMP documentation. At TBD, we have plenty of experience with the EU centralised registration procedure, as well as significant experience in Canada, Australia, New Zealand, and other parts of the world.

If you’re developing a generic drug, our QA specialists will prepare the full ASMF documentation package (with both open and closed parts). If you’re developing a novel drug or a therapy, we’ll provide you with full CMC documentation, which will include all the technical information the authorities require.

If you need ASMF in CTD format, all you need to do is ask.