Authorized Representative (incl. EU AR & US Agent)

Authorized Representative (incl. EU AR & US Agent)

Procedure: Authorized RepresentativeCountry: Global ProcedureVersion #: 11/30/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-AR-SRCategory: PharmaceuticalsValidity: 1 year with optional extensionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc.   SUMMARY Legally Authorized Representative (AR, LAR, or US Agent in the United States) is a local person or legal entity appointed by foreign manufacturer to act on their behalf regarding certain regulatory obligations under local…

Pre-Sub Activities

Pre-Sub Activities

Procedure: Pre-Sub ActivitiesCountry: Global ProcedureVersion #: 11/30/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-PSA-SRCategory: PharmaceuticalsValidity: Until SubmissionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Pre-Sub Activities refer to the regulatory activities conducted by an National Regulatory Agency (NRA) prior to the submission of a marketing authorization application for a medicinal product.These activities aim to ensure that the…

Regulatory Compliance and Gap Analysis

Regulatory Compliance and Gap Analysis

Procedure: Regulatory Compliance and Gap AnalysisCountry: Global ProcedureVersion #: 11/27/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-GAP-SRCategory: PharmaceuticalsValidity: Until MA ApplicationCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Gap analysis involves assessing and identifying any shortcomings or gaps in a registration dossier compliance with local regulatory standards. These gaps could include missing documentation, incomplete testing, or lack of adherence to specific guidelines. Unlike risk…

Intellectual Property Rights Protection

Intellectual Property Rights Protection

Procedure: Intellectual Property Rights ProtectionCountry: Global ProcedureVersion #: 11/28/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-IP-SRCategory: Pharmaceuticals/MD&IVD/OthersValidity: IP Rights Expiration DateCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Intellectual Property Rights Protection in pharmaceuticals registrations refers to the legal mechanisms and regulations in place to safeguard the intellectual property of pharmaceutical companies. This includes patents, trademarks, copyrights, and trade secrets…

Regulatory Intelligence

Regulatory Intelligence

Procedure: Regulatory Intelligence Country: Global Procedure Version #: 11/28/2023 Author: Daria Kostiuchenko Editor: Daria Kostiuchenko ID: GP-PhR-RI-SRC Category: Pharmaceuticals/MD&IVD/Others Validity: Until next NRA update Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY Regulatory Intelligence involves up-to-date gathering, analysis, and interpretation of information regarding regulations and compliance requirements. Strategic consulting involves providing expert advice…