CMC Dossier definition
CMC Dossier means chemistry, manufacturing, and controls section of the Regulatory Approval for a Product (i.e., Module 3).
CMC Dossier means the technical information required by the relevant regulatory authority in relation to the chemistry, manufacturing and controls of PSA EPO for commencement of a Lipoxen Trial;
CMC Dossier means that portion of the Marketing Authorisation application dossier in the Territory relating to the manufacture and quality of the Bulk Product and/or Finished Product, including any variations, amendments or supplements thereto.
Examples of CMC Dossier in a sentence
The Seller shall take the actions as described on Section 6.19 of the Seller Disclosure Letter with respect to the CMC Dossier for the Product and any related Regulatory Filings, provided, however, that the Seller may modify or delay any actions or Regulatory Filings related to the CMC Dossier for the Product following consultation with the Purchaser.