CMC Documentation definition
CMC Documentation means the chemistry, manufacturing and controls section of a Regulatory Filing.
CMC Documentation means all information required to support the Chemistry, Manufacturing & Control section of any Regulatory Approval or submission of ONYX made in connection with the Material Manufactured under this Agreement.
Examples of CMC Documentation in a sentence
Project: CMC Documentation Timeline: 30 days Cost: *** Start Date: Per MS Project Timeline Process Steps: · AVID will generate the CMC documentation for an IND and/or NDA filing.
Exelixis shall prepare such CMC Documentation in accordance with applicable regulations and shall provide Helsinn with the completed CMC Documentation, along with the [ * ].
Spark will use commercially reasonable efforts to assist Novartis upon Novartis’ request with any interactions with such Regulatory Authorities in the Novartis Territory regarding the Manufacturing of the Drug Substance, including the preparation and provision of access to any CMC Documentation, at Spark’s cost and expense.