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Domain > regulatory.com.ua
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Date
IP Address
2013-07-09
77.87.192.70
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ClassC
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2024-09-14
89.184.95.96
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ClassC
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Port 443
HTTP/1.1 200 OKServer: nginxDate: Sat, 14 Sep 2024 02:31:09 GMTContent-Type: text/html; charsetUTF-8Transfer-Encoding: chunkedConnection: keep-aliveVary: Accept-EncodingLink: https://regulatory.com.ua/wp-json/>; relhttps://api.w.org/Link: https://regulatory.com.ua/wp-json/wp/v2/pages/37>; relalternate; titleJSON; typeapplication/jsonLink: https://regulatory.com.ua/>; relshortlinkVary: Accept-EncodingFront-End-Https: onStrict-Transport-Security: max-age300; !DOCTYPE html>html langen-US>head> meta charsetUTF-8 /> meta nameviewport contentwidthdevice-width,initial-scale1,user-scalableno> meta namedescription content510(k) – Premarket Notification for Medical Device aka PMNAADA – Abbreviated antibiotic drug applicationACTD – ASEAN common technical dossierADR – Adverse drug reactionAE – Adverse eventAIM – Active ingredient manufacturerAIMD – Active implantable medical deviceANDA – Abbreviated new drug applicationAPI – Active pharmaceutical ingredientAR – Assessment Report (European Union)ASMF – Active Substance Master FileATMPs – Advanced therapy medicinal productsBA – BioavailabilityBAP – Biotechnology Action ProgramBIND – Biological investigational new drugBLA - Biologic License ApplicationBWP – Biotech Working Party (EMA)C&P – Chemistry and PharmacyCA – Competent authorityCANDA – Computer assisted new drug applicationCAP – Centrally authorized productCAPA – Corrective action and preventive actionCAPLA – Computer Assisted Product License ApplicationCCDS – Company core data sheetCD – Controlled drugCDSCO – Central Drug Standard Organization (India)cGLP – Current good laboratory practicecGMP – Current good manufacturing practiceCl – Total body clearanceCLO – Clinical overviewCLS – Clinical summaryCMC – Chemistry – manufacturing – controlsCMP – Certificate of Medicinal ProductCOA – Certificate of analysisCoFS – Certificate of Free SaleCP – Centralized procedure (European Union)CP – Comparability protocol (USA)CPP – Certificate of pharmaceutical productCQA – Clinical quality assuranceCR – Controlled releaseCRO – Clinical Research OrganizationCSI – Core safety informationCSP – Core safety profileCSR – Clinical study report (European Union)CT – Clinical trialCTA – Clinical trial applicationCTA – Clinical trial authorizationCTD – Clinical Trials DirectiveCTD – Common technical document/dossierCTMS – Clinical trial management systemCTS – Common technical specificationCVM – Center for Veterinary Medicine (US)DACS – Detailed and critical summaryDAE – Discontinuation due to an adverse eventDDPS – Detailed description of pharmacovigilance systemDMF – Drug master fileDMS – Document management systemDP – Drug productDS – Drug substanceDSUR – Development safety update reportEA – Environmental assessmentEC – Ethics committeeeCTD – Electronic common technical documentEDMF – European drug master fileEDT – Electronic data transferENS – Early notification systemEPA – Environmental Protection AgencyEPL – Effective patent lifeePSUR – Electronic periodic safety update reportERB – Ethical review boardESPAR – Executive Summary Pharmacovigilance Assessment ReportEUA – Emergency Use AuthorizationEWG – Expert Working GroupEWP – Efficacy Working PartyFAR – Final assessment reportFMEA – Failure mode and effects analysisGCP – Good clinical practiceGDP – Good distribution practiceGeneric - Generic drugGGP – Good guidance practiceGLP – Good laboratory practiceGMP – Good manufacturing practiceGMP – Good management practiceGPP – Good pediatric practiceGPP – Good pharmacoepidemiology practiceGpvP – Good pharmacovigilance practiceGRB – Global Regulatory BoardGRP – Good regulatory practiceGSL – General sales listGSP – Good statistics practiceGVP – Good pharmacovigilance practiceHCP – Healthcare professionalHEOR – Health economics and outcomes researchHREC – Human Research Ethics CommitteeHTA – Health technology assessmentIB – Investigator’s brochureIC – Informed consentICD – Informed consent documentICSR – Individual case safety reportIDE – Investigational Device ExemptionIDMP – Identification of medicinal productsIEC – Independent ethics committeeIM – Issue managementIME – Important medical eventIMI – Innovative Medicines InitiativeIMP – Investigational medicinal productIMPD – Investigational medicinal product dossierIMRDF – International Medical Device Regulatory ForumIMS – Information management strategyINDA – Investigational new drug application (USA)INDC – Investigational New Drug CommitteeIP – Intellectual propertyIPO – Intellectual Property OfficeIPR – Intellectual property rightsIQM – Integrated quality managementIRB – Institutional review boardIRD – International registration documentIRN – Incident Review NetworkIS – Internal standardISE – Integrated summary of efficacyISRB – Integrated summary of risk benefitISS – Integrated summary of safetyKIT – Key intelligence topicKM – Knowledge managementKOL – Key opinion leaderLCM – Lifecycle managementLLL – Lifelong learningMA – Marketing authorizationMAA – Marketing authorization application (EU)MAH – Marketing authorization holderMAIL – Medicines Act Information Letter (UK)MAL – Medicines Act Leaflet (UK)MDCG – Medical Device Coordination GroupMDD – Medical Device DirectiveMDEG – Medical Device Expert GroupMDLO – Medical Device Liaison OfficerMDR – Medical device reportingMERS – Multi-agency electronic regulatory systemMHRA – Medicines and Healthcare products Regulatory Agency (UK)ML – Manufacturer’s license (UK)MOU – Memorandum of UnderstandingMRA – Mutual recognition agreementNAP – Nationally authorized productNBE – New biological entityNCE – New chemical entityNCO – Non clinical overviewNCS – Non clinical summaryNDAC – New Drug Advisory Committee (India)NIMP – Non-investigational medicinal productNME – New molecular entityOD – Orphan drugODA – Orphan Drugs Act (USA)ODD – Orphan drug designationOIA – Official action indicatedOOS – Out of specificationOTC – Over-the-counter drugsP&R – Pricing and reimbursementP – Pharmacy onlyP to GSL – Pharmacy to General Sales ListPA – Product authorizationPAI – Pre-approval inspectionPAR – Preliminary assessment reportPASS – Post authorization safety studyPAT – Process analytical technologyPDE – Personal daily exposurePER – Pharmaceutical evaluation reportPGD – Patient group directionPI – Prescribing informationPI – Production informationPIL – Patient information leafletPIM – Product information management (EMA)PIP – Pediatric investigation planPMS study – Post-marketing safety studyPMS – Postmarket(ing) surveillancePOM – Prescription-only medicinePOM to P – Prescription-only medicine to pharmacyPPI – Patient and Public Involvement (UK)PRSPH – Potential serious risk to public healthPSMF – Pharmacovigilance system master filePTE – Patent term extensionPUMA – Pediatric-use marketing authorizationPV – PharmacovigilancePVAR – Preliminary Variation Assessment ReportQA – Quality assuranceQbD – Quality by designQC – Quality controlQMS – Quality management systemQOL – Quality of lifeQoS – Quality overall summaryQP – Qualified personQPPV – Qualified person for pharmacovigilanceQRD – Quality review of documents templateRA – Regulatory affairsRAPS - Regulatory Affairs Professionals SocietyRCFID – Registration Certificate for Import of DrugRCT – Randomized controlled trialRDE – Remote data entryRDS – Repeat dose studyRDT – Rising-dose toleranceREACH – Registration, evaluation, authorization, restriction of chemicalsRI – Regulatory intelligenceRING – Regulatory Intelligence Network GrouprINN – Recommended international non-proprietary nameRMM – Risk minimization measureRMP – Reference medicinal productRMR – Reaction monitoring reportROI – Return on investmentRoW – Rest of worldRP – Responsible personRPS – Regulated product submissionRx – PrescriptionS+T – Sampling and testingSAG – Scientific Advisory GroupSAP – Scientific advice procedureSAWP – Scientific Advice Working PartySI – Statutory instrumentSLA – Service level agreementSME – Significant medical eventSMF – Site master file SMO – Site management organizationSMQ – Standardized MedDRA querySOP – standard operating procedureSPIN – Special interest networkSSC – Scientific Steering CommitteeTAG – Therapeutic Advisory GroupTLV – Threshold limit valueTOC – Table of contentsTOD – Table of decisionsTOPRA – The Organization for Professionals in Regulatory AffairsTPP – Target product profileUSDA – United States Department of AgricultureVAI – Voluntary action indicatedWC – Written confirmationWL – Wholesale dealer’s licenseWRAC – Worldwide Regulatory Affairs CommitteeWHO - World Health Organization> meta namekeywords contentRegistration procedures, Registration, Renewal, Variations, Registration of medical devices, Registration of medical equipment, Registration of medical products, Registration of substances, Registration of API, Registration of Generics, Registration of food supplements, Registration of nutrition, Registration of cosmetics, Registration of cosmeceuticals, Registration of orphan Drugs, Registration by the State Expert Center, MOH Ministry of Health, Positive conclusion, Pharma, Drug, Drugs, Pharmaceuticals, Pharmacovigilance, BioTech, Biologics, Biosimilars, Health Claims, Market Authorization, Registration, Free Sales Certificate, Product Permission, Emergency Use Authorization, EUA, FDA, USFDA, US FDA, EMA Pre-marketing Notifications, Cratia, GMP Certificate, GMP Clearance, GMP Conclusion, GMP RECOGNITION, Healthcare Regulatory Affairs Expediting, RA Global network, Patern, Pattern, Patern Ltd., Pattern of USA, Approval, Gap analysis, Consulting for compliance to licensing requirements, Administrative and financial consulting, Legal support, Intellectual Property, Successful procedures, Professional team, Medical & ex-government professionals, Development of compliance reports based on customer inputs, CRM, Quality Management System, QMS, Membership, Regulatory Affairs: Market Authorization and post-marketing compliance, Regulatory Intelligence, local regulations, Market Entry, Generics, Project management, Legislation, regulatory affairs cost, PIC/S, ESTABLISHMENT REGISTRATION, Protocol of the dossier internal expertise, Current legislation, Instruction, leaflet, labeling, medical use, Regulatory compliance, registration strategy, Regulatory operations, Registration, notification, dossiers, CTD, technical dossiers, Safety assessment, Health claims validation, State procedure, State Authority, FDA, EPA, CBER, USDA, EMA, MHRA, CIS Regulatory Authorities, Pharmalink, RAPS, RAPA, Pharmareg, Pharmagate, Farmagate, Kraita, Фармагейт, Кратия, Local Regulatory Authority, EU, US, UK, Switzerland, Middle East, Central Asia, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan, Ukraine, New York, Miami, Kiev > link relprofile hrefhttp://gmpg.org/xfn/11 /> link relpingback hrefhttps://regulatory.com.ua/xmlrpc.php /> title>Pattern of USA Inc. | Regulatory Affairs Outsourcing ft Pattern of USA Inc. 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clearfix>div classwpb_column vc_column_container vc_col-sm-1/5>div classvc_column-inner>div classwpb_wrapper>div classq_counter_holder center style data-digit41>span classcounter random stylefont-size: 30px;font-weight: 600;>41/span>span classseparator small stylebackground-color: #8488e9;>/span>p classcounter_text stylefont-size: 20px;font-weight: 300;>Medical Devices/p>/div>/div>/div>/div>div classwpb_column vc_column_container vc_col-sm-1/5>div classvc_column-inner>div classwpb_wrapper>div classq_counter_holder center style data-digit31>span classcounter zero stylefont-size: 30px;font-weight: 600;>31/span>span classseparator small stylebackground-color: #8488e9;>/span>p classcounter_text stylefont-size: 20px;font-weight: 300;>RA Intell/p>/div>/div>/div>/div>div classwpb_column vc_column_container vc_col-sm-1/5>div classvc_column-inner>div classwpb_wrapper>div classq_counter_holder center style data-digit1367>span classcounter zero stylefont-size: 30px;font-weight: 600;>1367/span>span classseparator small stylebackground-color: #8488e9;>/span>p classcounter_text stylefont-size: 20px;font-weight: 300;>Pharmaceuticals/p>/div>/div>/div>/div>div classwpb_column vc_column_container vc_col-sm-1/5>div classvc_column-inner>div classwpb_wrapper>div classq_counter_holder center style data-digit64>span classcounter zero stylefont-size: 30px;font-weight: 600;>64/span>span classseparator small stylebackground-color: #8488e9;>/span>p classcounter_text stylefont-size: 20px;font-weight: 300;>Pharmacovigilance/p>/div>/div>/div>/div>div classwpb_column vc_column_container vc_col-sm-1/5>div classvc_column-inner>div classwpb_wrapper>div classq_counter_holder center style data-digit12>span classcounter random stylefont-size: 30px;font-weight: 600;>12/span>span classseparator small stylebackground-color: #8488e9;>/span>p classcounter_text stylefont-size: 20px;font-weight: 300;>GMP compliance/p>/div>/div>/div>/div>/div>/div>div classvc_row wpb_row section vc_row-fluid vc_custom_1510311597147 style text-align:left;>div class full_section_inner clearfix>div classwpb_column vc_column_container vc_col-sm-12 vc_col-lg-6>div classvc_column-inner>div classwpb_wrapper>div classq_elements_holder one_column responsive_mode_from_768 >div classq_elements_item data-1024-12808px 0px 0px 0% data-768-10248px 15% 0px data-480-6008px 0% 0px data-4808px 0% 0px data-animationno data-item-classq_elements_holder_custom_851112>div classq_elements_item_inner>div classq_elements_item_content q_elements_holder_custom_851112 stylepadding:8px 0px 0px 17%> div classwpb_single_image wpb_content_element vc_align_center> div classwpb_wrapper> div classvc_single_image-wrapper vc_box_border_grey>img loadinglazy decodingasync width738 height810 srchttps://regulatory.com.ua/wp-content/uploads/2021/02/white-iphone-xr-mockup-transparent.001.jpeg classvc_single_image-img attachment-full alt srcsethttps://regulatory.com.ua/wp-content/uploads/2021/02/white-iphone-xr-mockup-transparent.001.jpeg 738w, https://regulatory.com.ua/wp-content/uploads/2021/02/white-iphone-xr-mockup-transparent.001-273x300.jpeg 273w, https://regulatory.com.ua/wp-content/uploads/2021/02/white-iphone-xr-mockup-transparent.001-700x768.jpeg 700w sizes(max-width: 738px) 100vw, 738px />/div> /div> /div>/div>/div>/div>/div>/div>/div>/div>div classwpb_column vc_column_container vc_col-sm-12 vc_col-lg-6>div classvc_column-inner>div classwpb_wrapper>div classq_elements_holder one_column responsive_mode_from_768 >div classq_elements_item data-1024-128015% 12% 0px 0% data-768-102470px 30% 0px 10% data-600-76870px 14% 0px 10% data-480-60070px 10% 0px data-48070px 10% 0px data-animationno data-item-classq_elements_holder_custom_713827>div classq_elements_item_inner>div classq_elements_item_content q_elements_holder_custom_713827 stylepadding:10% 10% 0px 0%> div classvc_empty_space styleheight: 28px >span classvc_empty_space_inner> span classempty_space_image >/span> /span>/div>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>Experience/h5>p classq_circle_text style>Est. 1998 | Thousands of successful procedures/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>Inspired Team/h5>p classq_circle_text style>Professional team doing RA since 1994/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>Advisory board/h5>p classq_circle_text style>Advisory board of pharma, medical & ex-gov professionals/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>Development/h5>p classq_circle_text style>Development of compliance reports based on customer inputs/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>QMS/h5>p classq_circle_text style>CRM-based Quality Management System recognized by ISO/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>24/7/h5>p classq_circle_text style>Modern project management 24/7 monitoring to meet deadlines/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>Lifecycle Management/h5>p classq_circle_text style>Meet expedited Regulatory Affairs/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>Cost Busters/h5>p classq_circle_text style>Reduced fixed costs of your company/p>/div>/li>li classq_circle_outer>span classq_circle_inner>span classq_circle_inner2 style>h3 classq_text_in_circle style>/h3>/span>/span>div classq_circle_text_holder>h5 classq_circle_title stylecolor: #f05050>Legislation updates/h5>p classq_circle_text style>Subscribe now/p>/div>/li>/div>/div>/div>/div>/div>/div>/div>/div>/div>div classvc_row wpb_row section vc_row-fluid style text-align:left;>div class full_section_inner clearfix stylepadding: 0% 0%>div classwpb_column vc_column_container vc_col-sm-12>div classvc_column-inner>div classwpb_wrapper>div classq_elements_holder one_column responsive_mode_from_768 >div classq_elements_item data-animationno data-item-classq_elements_holder_custom_426511>div classq_elements_item_inner>div classq_elements_item_content q_elements_holder_custom_426511 stylepadding:1% 1% 0px 0%> div classwpb_text_column wpb_content_element vc_custom_1614648714471> div classwpb_wrapper> h1>strong>Your key/strong> to foreign markets/h1> /div> /div> div classwpb_text_column wpb_content_element > div classwpb_wrapper> ul>li>Pattern of USA Inc. is founded in 2010 in New York City as a successor of Patern Ltd. reorganized in 2001 as Regulatory Affairs consulting group by healthcare professionals to service global Big Pharma & MedDevice/Equipment projects over Eastern Europe countries./li>li>Pattern of USA Inc. is an innovative, digitalized, and customer-friendly Regulatory Affairs company, that focuses on delivering smart solutions tailored to the Customers’ needs./li>li>We offer comprehensive Regulatory Affairs (RA) outsourcing service starting from Regulatory Intelligence to establishment registration consulting through the majority of RA procedures incl. Pharmaceuticals, BioTech, Biologics, Biosimilars, Medical Devices, Medical Equipment, Cosmeceuticals, Nutrition, Orphan Drugs, Supplements, Cosmetics, GMP recognition, Pharmacovigilance also Food Health Claims validation./li>li>Pattern of USA Inc. is a founder of RAPAhub, a digital solution for simplified RA accesabiltiy worldwide./li>/ul>div classelementor-column-wrap elementor-element-populated>div classelementor-widget-wrap ui-sortable>div id classelementor-element elementor-element-edit-mode elementor-element-15143a0 elementor-element--toggle-edit-tools elementor-widget elementor-widget-text-editor data-id15143a0 data-element_typewidget data-model-cidc194 data-widget_typetext-editor.default>div classelementor-element-overlay>div classelementor-widget-container>div classelementor-text-editor elementor-clearfix elementor-inline-editing data-elementor-setting-keyeditor data-elementor-inline-editing-toolbaradvanced>/div>/div>/div>/div>/div>/div> /div> /div> div classvc_empty_space vc_custom_1614648989403 styleheight: 35px >span classvc_empty_space_inner> span classempty_space_image >/span> /span>/div> div classwpb_text_column wpb_content_element vc_custom_1650482090986> div classwpb_wrapper> ul>li>h6>em>RA outsourcing with Pattern of USA Inc. will significantly reduce fixed costs benefiting local expertise and multilayer of professional skills./em>/h6>/li>li>h6>em>The success of Pattern of USA Inc. is based on 22 years of experience of reliable cooperation and representative service for European and overseas global companies and local manufacturers of healthcare products. We are the only company, that carried out the consulting services for various embassies of EU countries, the United Kingdom, Asia, and North America, recognized by the US Department of Commerce and Canada Commercial Attaché office.span classApple-converted-space> /span>/em>/h6>/li>li>h6>em>Patern Ltd. under the management of Pattern of USA Inc. has successfully passed the ISO 9001 certification by TÜV Rheinland Group, Germany for many years./em>/h6>/li>li>h6>em>With Pattern of USA Inc. partnership network and local expeditors, we serve EU, US, UK, Switzerland, Middle East, and Central Asia including CIS countries from our offices in New York, Miami, and overseas.span classApple-converted-space> /span>/em>/h6>/li>li>h6>em>We can apply to FDA, EPA, CBER, USDA, EMA, MHRA, Local CIS & Asia Regulatory Authorities under your PoA/em>/h6>/li>/ul> /div> /div> div classvc_empty_space styleheight: 20px >span classvc_empty_space_inner> span classempty_space_image >/span> /span>/div>/div>/div>/div>/div>/div>/div>/div>/div>/div>div classvc_row wpb_row section vc_row-fluid vc_custom_1510311792060 grid_section style text-align:left;>div class section_inner clearfix>div classsection_inner_margin clearfix>div classwpb_column vc_column_container vc_col-sm-6 vc_col-lg-6>div classvc_column-inner vc_custom_1510235174232>div classwpb_wrapper>div classq_elements_holder one_column responsive_mode_from_768 >div classq_elements_item data-1280-14400px 0px data-1024-12800px 0px data-768-10240px 27% 0px 6% data-600-7680px data-480-6000px data-4800px data-animationno data-item-classq_elements_holder_custom_984556>div classq_elements_item_inner>div classq_elements_item_content q_elements_holder_custom_984556 stylepadding:70px 0px 0px> div classwpb_text_column wpb_content_element > div classwpb_wrapper> h2>We are Local for your Global success/h2> /div> /div> div classvc_empty_space styleheight: 28px >span classvc_empty_space_inner> span classempty_space_image >/span> 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