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. 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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Examples of Regulatory Support in a sentence

  • Regulatory support such as product domain regulatory considerations, regulatory planning, and regulatory strategy development.The Army SBIR program sponsors participation in the TABA program.

  • Regulatory support and technical advances in controls, communications, and metering led to a marked increase in load management, particularly direct load control programs and interruptible/curtailable service tariffs.

  • Regulatory support is required to operate the high-altitude, unmanned balloons, and toutilize spectrum bands without interfering with existing satellite and terrestrial companies.

  • Regulatory support will be required for both the operation of high altitude, unmanned aircrafts, and to utilize spectrum bands without interfering withexisting satellite and terrestrial companies.

  • Regulatory support and approval will be required for the commercialization of the company's Kenyan Contingent Resources to proceed.

  • Regulatory support for a Price Cap Plan of a Local Gas Distribution Utility.

  • Regulatory support activities under this PWS do not include public outreach or public affairs support.

  • Regulatory support schemeWhile most cities in Japan are limited in their capacities, some larger cities have taken the initiative to lead ambitious climate action.

  • The Commission continually provides Regulatory support in exploring new products for purchase of Renewable Energy as a step in promoting clean sources of energy in the interest of consumer.

  • Thalassemia, characterized by less hemoglobin and fewer red blood cells than normal, can also cause anemia.


More Definitions of Regulatory Support

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 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 has the meaning set forth in Section 3.2.
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Regulatory Support has the meaning set forth in Section 5.6 (Cooperation).
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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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Regulatory Support has the meaning set forth in Section 4.1.7. 1.207
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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 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 approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable 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 any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Technical Support Services means the technical support and maintenance Services provided by us according to our then-current technical support policy and procedure listed at xxxxxxxxxxxxx.xxx (“Technical Support Policy”) when the Services are purchased.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • Regulatory Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Product Complaint means any oral, electronic or written communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a marketed product, including failure of the product, labelling or packaging to meet specifications, whether or not the product is related to or caused the alleged deficiency. A complaint may allege that an Adverse Event or Medical Device Malfunction (as defined herein) has occurred.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Regulatory Action means an administrative, regulatory, or judicial enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, injunction or consent decree, issued by the FDA or a federal or state court.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Regulatory Bodies means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate, investigate, or influence the matters dealt with in the Contract or any other affairs of the Authority and “Regulatory Body” shall be construed accordingly.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.