Regulatory support, definition

Regulatory support, which means helping respond to data requests or other information requests from governmental bodies or third parties in regulatory matters; helping prepare testimony; and helping prepare filings in regulatory proceedings.
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Regulatory support, means (a) the design and performance of stability studies for the Investigational Medicinal Product, and (b) the updating of Investigational Medicinal Product regulatory filings with data generated from said stability studies.
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Regulatory support, has the meaning set forth in Section 5.6 (Cooperation).
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Examples of Regulatory support, in a sentence

  • Regulatory support services that are identified in ANNEX 4, shall be [**] to Zavante; additional regulatory consulting services (not listed in ANNEX 4) shall be billed at ERN’s [**].

  • Regulatory support services, as identified in Exhibit 7, shall be at no additional charge to Barrier; regulatory consulting services shall be billed at DSM’s standard hourly rates and payable pursuant to Section 8.4 of this Agreement.

  • Regulatory support services, as identified in Appendix E, shall be at no additional charge to ORPHAN; regulatory consulting services shall be billed at Catalytica’s standard hourly rates and payable pursuant to Section 7.7 of this Agreement.

  • Regulatory support services, as identified in ANNEX 4, shall be at no additional charge to OMEROS; regulatory consulting services shall be billed at DSM’s standard hourly rates.

  • Regulatory support and exchanges shall be conducted in accordance with Section 5.3 of the License Agreement.

  • The Services to be performed by Point Guard under this SOW are for the following activities: · General management and strategy · Accounting · CMC support services · Regulatory support and representation at the FDA · Legal and administrative support See Attachment A for a detailed breakdown of personnel and activities.

  • Regulatory support and exchanges shall be conducted in accordance with Section 5.3 of the License which is set out in Appendix 4 attached hereto.

  • Regulatory support work is subject to an additional fee and will be charged at a rate of [***].

  • Regulatory support for the legal positioning of the products in Europe.

  • Regulatory support services, as identified in ANNEX 4, shall be at no additional charge to AMAG; regulatory consulting services shall be billed at DSM’s standard hourly rates and payable pursuant to Section 7.4 of this Agreement.


More Definitions of Regulatory support,

Regulatory support,. Upon request, Seller shall provide information necessary for Align to obtain regulatory approval for the marketing, sale, and distribution of Align products into which the Seller's products or services are incorporated. Such information may include specific details relating to raw materials, composition, ingredients, etc.
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Regulatory support, has the meaning set forth in Section 3.2.
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Regulatory support, is any evaluation of Supplier’s data that is required to assist any WERCSmart Recipient in complying with any statute or regulation applicable in the United States or other countries (including international laws and regulations), governing the sale, handling, transportation, storage or disposal of products containing chemicals. These evaluations are included in the “WERCSmart Results” which are provided to WERCSmart Recipients to support their regulatory compliance programs. WERCSmart Results are derived using both Public Data and Confidential Data submitted by a Direct Supplier (and its Third-Party Suppliers). WERCSmart Results also include the provision of product safety data sheets, whether authored by the Direct Supplier or by UL authoring services.
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Regulatory support, means (a) the design and performance of stability studies for the Investigational Medicinal Product, and (b) the updating of
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Regulatory support, has the meaning set forth in Section 4.1.7.
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Regulatory support, which means helping respond to data requests or other information requests from governmental bodies or third parties in regulatory
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Related to Regulatory support,

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Services Provider means the organization which provides regulatory services to BSEF pursuant to a Regulatory Services Agreement.

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • Regulatory Filings means all applications, approvals, licenses, notifications, registrations, submissions and authorizations made to or received from a Regulatory Authority in the Territory necessary for the development, manufacture or commercialization of a pharmaceutical product, including any INDs, NDAs and Regulatory Approvals.