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.
CMC Documentation means the Chemistry, Manufacturing and Controls section of a Regulatory Approval.

Examples of CMC Documentation in a sentence

  • Xx. Xxxx Xxxxxx has 5 years’ academic and 25 years’ Biotech and Biopharmaceutical Industry experience in Research and Development, Quality Systems, Quality Control, Compliance, Analytical Method Development and Validation, CMC Documentation, Project Management, cGMP/GLP/FDA/USP/ICH compliance.

  • 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.

  • 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 xxx.xxxxxx.xxx/xxxxx, as updated by Vocera from time to time.

  • 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 xxxx://xxxxxx.xxx/contracts or such other address specified by Oracle.

  • User Documentation means explanatory and informational materials concerning the Company products, in printed or electronic format, which the Company or any Subsidiary has released for distribution to end users with such Company products, which may include manuals, descriptions, user and/or installation instructions, diagrams, printouts, listings, flow-charts and training materials, contained on visual media such as paper or photographic film, or on other physical storage media in machine readable form.

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Software Documentation means software information, being technical information used, or useful in, or relating to the design, development, use or maintenance of any version of a software programme.

  • Design Documentation means all schematics and test, assembly and package documentation relating to the Product, including all design, specification and assembly documentation and data files for Materials, which is necessary for the production, manufacture, qualification, testing and delivery of the Product to be attached as Exhibit A.

  • Acquisition Documentation collectively, the Acquisition Agreement and all schedules, exhibits and annexes thereto and all side letters and agreements affecting the terms thereof or entered into in connection therewith.

  • Limited Documentation Program The guidelines under which the Seller generally originates Mortgage Loans principally on the basis of the Loan-to-Value Ratio of the related Mortgage Loan and the creditworthiness of the Mortgagor.

  • Supporting Documentation means the documents listed in Schedule A of this Certificate which forms part of this

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • Account Documentation means any and all Account information, credit applications, Cardholder Agreements and change in terms notices, Charge Transaction Data, charge slips, credit slips, payments, credit information and documents or forms of any type and in any media relating to the Program, excluding materials used for advertising or solicitations.

  • Security Documentation means the Security Documentation applicable to the specific Services purchased by Client, as updated from time to time, and as made reasonably available by Securiti.

  • Flood Documentation means, with respect to each Mortgaged Property located in the United States of America or any territory thereof, (i) a completed “life-of-loan” Federal Emergency Management Agency standard flood hazard determination (to the extent a Mortgaged Property is located in a Special Flood Hazard Area, together with a notice about Special Flood Hazard Area status and flood disaster assistance duly executed by the Borrower and the applicable Loan Party relating thereto) and (ii) a copy of, or a certificate as to coverage under, and a declaration page relating to, the insurance policies required by Section 5.02(c) hereof and the applicable provisions of the Security Documents, each of which shall (A) be endorsed or otherwise amended to include a “standard” or “New York” lender’s loss payable or mortgagee endorsement (as applicable), (B) name the Collateral Agent, on behalf of the Secured Parties, as additional insured and loss payee/mortgagee, (C) identify the address of each property located in a Special Flood Hazard Area, the applicable flood zone designation and the flood insurance coverage and deductible relating thereto and (D) be otherwise in form and substance reasonably satisfactory to the Collateral Agent.

  • Computer software documentation means owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

  • Co-Documentation Agent as defined in the preamble hereto.

  • Definitive Documentation means the definitive documents and agreements governing the Restructuring Transactions as set forth in the Restructuring Support Agreement.

  • ISM Code Documentation means, in relation to a Vessel, the document of compliance (DOC) and safety management certificate (SMC) issued by a Classification Society pursuant to the ISM Code in relation to that Vessel within the periods specified by the ISM Code;

  • Co-Documentation Agents as defined in the preamble hereto.

  • Programme Document means each of the Master Trust Deed, the Agency Agreement, the Registrar Agreement, the Margin Account Agreement, the Margin Account Security Agreement, the Portfolio Administration Agreement, the Operating Procedures Agreement, the Determination Agency Agreement, the Broker Dealer of Record Agreement, the Services Agreement and each Authorised Participant Agreement and "Programme Documents" means all such documents.

  • Streamlined Documentation Mortgage Loan Any Mortgage Loan originated pursuant to the Seller's Streamlined Loan Documentation Program then in effect.

  • Program Know-How which means any and all Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case (i) by or on behalf of [***], (ii) by or on behalf of [***] or (iii) by or on behalf of [***], but expressly excluding any Joint Program Know-How.