Cosmetics MA
Procedure: Cosmetics MACountry: Global Procedure Version #: 01/15/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-OTH-CMA-SRCategory: OthersValidity: Lifetime or 5-years, or country-specificCertified by: Vlad…
Disinfectants MA
Procedure: Disinfectants MA Country: Global Procedure Version #: 01/11/2024 Author: Daria Kostiuchenko Editor: Vlad Reznikov ID: GP-DIS-MA-SR Category: Disinfectants Validity: Defined by NRA, until renewal or change Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY Disinfectant, including antiseptics requirements and market authorization vary globally, subject to the regulations of individual countries or regions….
Food Supplements MA
Procedure: Food Supplements MA Country: Global ProcedureVersion #: 01/09/2024Author: Maria IvanovaEditor: Vlad Reznikov ID: GP-SUP-MA-SRCategory: SupplementsValidity: Defined by NRA, until renewal or changeCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY The global regulation of food supplements involves diverse requirements and market authorization processes, shaped by the distinct regulations of individual countries or regions. This…
Advert., Labeling and Claims Compliance Check
Procedure: Commercial Ad, Labeling and Health Claims Compliance Check Country: Global Procedure Version #: 01/05/2024 Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: GP-PhR-CLH-SR Category: Pharmaceuticals/MD&IVD/Others Validity: Until next NRA update Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY A Commercial Ad, Labeling, and Health Claims Compliance Check for healthcare products involves a thorough…
Single Lay User Prototype UI/UX Testing
Procedure: Single Lay User Prototype UI/UX TestingCountry: Global ProcedureVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-MD-PTS-SRCategory: MD&IVD/OthersValidity: NACertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Single Lay User Prototype UI/UX Testing is integral to the success of a healthcare startup developing medical devices. It aligns the design with user needs, identifies potential challenges,…
CARES Act Reporting
Procedure: CARES Act Reporting Country: United States Version #: 01/03/2024 Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: US-PhR-CRS-SR Category: Pharmaceuticals/Others Validity: Annual Reporting Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY The U.S. FDA CDER NextGen Portal Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Reporting initiative streamlines and enhances the reporting process,…
NRA Classification
Procedure: NRA ClassificationCountry: Global ProcedureVersion #: 11/28/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-CLS-SRCategory: PharmaceuticalsValidity: Until MA obtaining or NRA updateCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Divergent classification by national regulatory agencies is pivotal for companies to align with the distinct requirements of each target market. In the realm of regulatory affairs, it plays a crucial role…
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…
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
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
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…