CMC Documentation definition

CMC Documentation means the chemistry, manufacturing and controls section of a Regulatory Filing.
View Source
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.
View Source

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.

Related to CMC Documentation

  • Related Documentation means, with respect to Software, all materials, documentation (including control documentation utilized in connection with an audit), specifications, technical manuals, user manuals, flow diagrams, file descriptions and other written information that describes the function and use of such Software, but excluding source code.

  • Product Documentation means the specific materials listed under “Documentation” at

  • Program Documentation refers to the user manuals, help windows, readme files for the Services and any Oracle Software. You may access the documentation online at ▇▇▇▇://▇▇▇▇▇▇.▇▇▇/contracts or such other address specified by Oracle.

  • User Documentation means that documentation regarding the operation, guidelines and features and functionality of Clover Insights that is made available to you from time to time at the website, by internet link or otherwise. User Documentation may be modified from time to time by First Data or its third party provider(s).

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all clinical studies and tests, including the manufacturing batch records, relating to the Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.