Regulatory audit definition

Regulatory audit is defined in the statute and means an audit of an eligible entity:
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Regulatory audit has the meaning set forth in Section 6.2 of Exhibit 2 (Legal Terms).
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Regulatory audit means the audit of a quality system is to demonstrate conformity with a quality system standard and the relevant regulatory requirements.
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Examples of Regulatory audit in a sentence

  • Regulatory audit procedures.TITLE I—UNITED STATES CUSTOMS SERVICESubtitle A—Drug Enforcement and Other Noncommercial and Commercial OperationsSEC.

  • Regulatory audit of Raj eSign infrastructure will be a continuous process as stipulated by the CCA.

  • Regulatory audit work consists of the audit of regulatory disclosures.

  • NOF will communicate within two (2) business days any Regulatory audit observations that impact the quality of product(s) supplied to SAVIENT or SAVIENT third-party contractors.

  • Amounts paid or payable to the auditor for:2016$0002015$000Audit of financial statements Audit of financial statements195215Review of interim financial statements3535Other assurance services Regulatory audit services112121Trustee reporting55 347376Regulatory audit services consists of the audit of regulatory disclosure statements and the compliance statements.

  • Regulatory audit, combined with policing of customs fraud, had made it possible to be very selective in devanning and inspecting shipments.

  • Auditor's remuneration 2021$'0002020$'000Audit of financial statements Audit and review of financial statements1386.0233.0Other services Regulatory audit work250.150.0Other services353.325.0Total fees paid to auditor489.4308.01 The audit fee includes fees for both the annual audit of the financial statements and the review of the interim financial statements.

  • CIRB Assistance with Response to Network Group Audits for Studies Under the CIRB Regulatory audit deficiencies related to amendment approvals should not be identified because all amendments are CIRB-approved when distributed by the Network Group.

  • Regulatory audit will form a significant part of departmental clinical audit programmes, these regulatory audits have mandated absolute standards –when they are undertaken locally they can be used to complement the process of inspection (by the relevant national radiation protection competent authority).

  • The two most common types of reviews of research records that take place at the Atlanta are study team self audits and Atlanta VAMC Research Compliance Office (RCO) regularly scheduled audits (annual Informed Consent audit and triennial Regulatory audit).


More Definitions of Regulatory audit

Regulatory audit shall have the meaning set forth in Section 16.1.
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Related to Regulatory audit

  • Regulatory Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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 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 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.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Action means an administrative or regulatory 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, or consent decree, issued by the FDA.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Regulatory entity means any board, commission, agency,

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • 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 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.

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

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • 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 Agency means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Applicable Insurance Regulatory Authority means, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in (x) the state or other jurisdiction in which such Insurance Subsidiary is domiciled or (y) to the extent asserting regulatory jurisdiction over such Insurance Subsidiary, the insurance department, authority or agency in each state or other jurisdiction in which such Insurance Subsidiary is licensed, and shall include any Federal insurance regulatory department, authority or agency that may be created in the future and that asserts regulatory jurisdiction over such Insurance Subsidiary.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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.