{"id":952,"date":"2022-09-19T19:57:26","date_gmt":"2022-09-19T19:57:26","guid":{"rendered":"https:\/\/awrightpath.net\/?page_id=952"},"modified":"2023-01-27T19:30:01","modified_gmt":"2023-01-28T00:30:01","slug":"our-services","status":"publish","type":"page","link":"https:\/\/awrightpath.net\/our-services\/","title":{"rendered":"Our services"},"content":{"rendered":"\t\t
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Regulatory Consulting & Strategy Services<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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We\u2019re more than just an <\/span>FDA compliance consultant<\/span>! At A Wright Path, we view our clients as business partners and work with you to develop strategies that best benefit your business. Our partnership is built on excellence, integrity, passion and social conscience. As your business partners, we stay abreast of today\u2019s quickly changing <\/span>regulatory requirements<\/span> to take your business into the future. Our <\/span>regulatory<\/span> and quality <\/span>consulting services<\/span> will help you gain clearance, maintain compliance and improve your overall quality. Here\u2019s how we\u2019ll get your business on The Right Path, Right Now!<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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REGULATORY AFFAIRS<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Expedite your <\/span>product development<\/span> and hit the global marketplace with maximum <\/span>regulatory compliance<\/span> in <\/span>FDA<\/span> Regulatory Submissions<\/span>, <\/span>CE marking<\/span> and more \u2014 while avoiding hurdles.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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  • Regulatory<\/span> Intelligence<\/span><\/li>
  • Regulatory Strategy<\/span><\/li>
  • Worldwide Registrations and Approvals (Asia \/ Australia \/ China \/ Japan \/ Latin America) \u2013 <\/span>Medical Devices<\/span> \/ Combination Products \/ Cosmetics<\/span><\/li>
  • Establishment of Registration and Device Listing<\/span><\/li>
  • Designated <\/span>U.S. Agent<\/span> for Foreign Manufacturers<\/span><\/li>
  • IDE Application, IDE Supplement and Annual IDE Reporting<\/span><\/li>
  • CE Marking<\/span> \/ European Directive (Technical File \/ Design Dossier)<\/span><\/li>
  • 510 (k) <\/span>Regulatory Submissions<\/span> \u2013 Traditional, Special and Abbreviated<\/span><\/li>
  • 513 (g) Request<\/span><\/li>
  • de Novo Petition<\/span><\/li>
  • HUD and HDE Application<\/span><\/li>
  • FDA<\/span> (<\/span>Food and Drug Administration<\/span>) Q-Sub Process<\/span><\/li>
  • CE Marking<\/span> (Technical File\/Design Dossier\/STED)<\/span><\/li>
  • CMDR Licensing \u2013 Canada<\/span><\/li>
  • Regulatory<\/span> Standards <\/span>Assessment<\/span> \/ Gap Analysis<\/span><\/li>
  • Regulatory<\/span> Deficiencies (483 \/ <\/span>Warning Letter<\/span> \/ Consent Decree)<\/span><\/li>
  • Liaison and Communications with <\/span>Regulatory<\/span> Agencies<\/span><\/li>
  • Regulatory<\/span> review of <\/span>Labeling<\/span> and Marketing Materials<\/span><\/li>
  • Letter to File<\/span><\/li>
  • FDA Inspection, Certificates and Permits<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \"\"<\/figure>

    A Quality Management System (QMS) defines how a company will achieve the creation and delivery of the products and services. As a regulatory and quality consulting firm, A Wright Path will aid in setting up and maintaining your QMS to meet your requirements and global regulations.\n<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    QUALITY MANAGEMENT SYSTEMS (QMS)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Develop, implement and sustain your <\/span>Quality Management System<\/span> for compliance with global <\/span>regulatory requirements<\/span>, including <\/span>FDA regulations<\/span>, <\/span>ISO<\/span> standards and <\/span>Good Manufacturing Practices<\/span> (<\/span>GMP<\/span>).<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    • Quality Management System<\/span> Development and Implementation<\/span><\/li>
    • FDA<\/span> Quality System Regulation (QSR)<\/span><\/li>
    • MDD\/MDR<\/span><\/li>
    • MDSAP (Australia, Brazil, Canada, United States, Japan)<\/span><\/li>
    • ISO<\/span> 13485 (2016)<\/span><\/li>
    • ISO<\/span> 9001 (2015)<\/span><\/li>
    • Cosmetics <\/span>Good Manufacturing Practices<\/span> (<\/span>GMP<\/span>) \u2013 <\/span>ISO<\/span> 22716<\/span><\/li>
    • DAMAS Quality System \u2013 NADL<\/span><\/li>
    • Other Global <\/span>Regulatory Requirements<\/span><\/li>
    • Quality System Support \/ Maintenance<\/span><\/li>
    • Quality System Integration \/ Quality System Projects \/ Due Diligence<\/span><\/li>
    • Standard Operating Procedures (SOP<\/span>)<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      QUALITY ASSURANCE<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Ensure all the planned and systematic activities are implemented within the <\/span>quality management system<\/span> to provide confidence in a quality product or service.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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      • Manufacturing Process and Equipment <\/span>Validation<\/span><\/li>
      • pFMEA<\/span><\/li>
      • Facility Qualification \/ Manufacturing Transfer Facility Qualification<\/span><\/li>
      • Internal <\/span>Audits<\/span><\/li>
      • Gap <\/span>Assessments<\/span> \/ <\/span>FDA<\/span> \/ <\/span>Regulatory<\/span> Body Pre-<\/span>Audit<\/span> Preparation<\/span><\/li>
      • Supplier Evaluation \/ <\/span>Audits<\/span><\/li>
      • FDA<\/span> \/ <\/span>Regulatory<\/span> Body Mock <\/span>Audit<\/span> Inspections<\/span><\/li>
      • Due Diligence <\/span>Audit<\/span><\/li>
      • QMS<\/span> Training and Staff Development<\/span><\/li>
      • Internal Auditor Training<\/span><\/li>
      • DAMAS Training<\/span><\/li>
      • Microbiology <\/span>Assessment<\/span> \/ Cleanroom Monitoring \/ <\/span>Validation<\/span><\/li>
      • Cleaning Process <\/span>Validation<\/span> and <\/span>Assessment<\/span> \/ Reusable <\/span>Medical Devices<\/span><\/li>
      • Medical Device<\/span> Failure Analysis<\/span><\/li>
      • Pre-Submissions and Pre-Market <\/span>Notifications<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        \"\"<\/figure>

        The Right Path, Right Now implements and maintains your quality management system to consistently meet customer expectations and regulatory requirements.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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        DESIGN QUALITY ASSURANCE<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Define global <\/span>regulatory<\/span> and customer requirements to ensure compliant products and patient safety.<\/span><\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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        • Combination Products (Devices \/ Drugs \/ <\/span>Biologics<\/span>)<\/span><\/li>
        • Medical Devices<\/span> \/ <\/span>Biologics<\/span> \/ Consumer Products \/ Cosmetics<\/span><\/li>
        • Project Management<\/span> \/ Design Controls \/ Design Transfer \/ DHF<\/span><\/li>
        • Usability and Human Factors (IEC 62366 and ANSI \/ AAMI HE75)<\/span><\/li>
        • Safety Risk Management (<\/span>ISO<\/span> 14971)<\/span><\/li>
        • Design Assurance \/ Verification \/ <\/span>Validation<\/span><\/li>
        • External Standards and Guidance Maintenance<\/span><\/li>
        • UDI (Unique Device Identification)<\/span><\/li>
        • Sterilization <\/span>Validation<\/span> (EO, Gamma, Steam and HPV)<\/span><\/li>
        • Biocompatibility Testing and Risk <\/span>Assessment<\/span><\/li>
        • Packaging Validation<\/span> and Sterile Packaging <\/span>Validation<\/span> (<\/span>ISO<\/span> 11607) 0 (New, Modified, Adoptions)<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          \"\"<\/figure>

          We offer the Right Path, Right Now\u00ae to define global regulatory and customer requirements to ensure compliant products and patient safety.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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          CLINICAL TRIAL & STRATEGY<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Expedite your <\/span>product development<\/span> and hit the global marketplace with maximum <\/span>regulatory compliance<\/span> in Clinical Trial Strategy, Clinical Trial Monitoring, Clinical Trial <\/span>Regulatory Submissions<\/span> and more. <\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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          • Clinical Trial Strategy \u2014 Feasibility\/Pilot and Pivotal\/Multi-Center<\/span><\/li>
          • Protocol Development and associated clinical trial documents (case report forms, informed consent forms, clinical monitoring plans)<\/span><\/li>
          • Clinical Protocol Amendments<\/span><\/li>
          • IRB Approvals<\/span><\/li>
          • IDE Applications, Supplements and Annual\/Periodic Reporting<\/span><\/li>
          • Informed Consent Requirements<\/span><\/li>
          • Study Design<\/span><\/li>
          • Study Execution and Monitoring<\/span><\/li>
          • Managing Clinical Trials (Domestic and International)<\/span><\/li>
          • Clinical Evaluation Process \u2014 Clinical Evaluation Reports (CER), MEDDEV 2.7\/1 Rev 4 – CEPs, CERs, PMCF Plans, PMCF Reports<\/span><\/li>
          • Safety Activities \u2014 Post-Market Surveillance\/Complaints, Health Risk <\/span>Assessments<\/span> (HRAs), MDRs<\/span><\/li>
          • Selection and management of CROs, core labs, and other vendors<\/span><\/li>
          • EDC database design, validation<\/span>, and management<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            \"\"<\/figure>

            The Right Path, Right Now implements and maintains your quality management system to consistently meet customer expectations and regulatory requirements.\n<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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            \"\"<\/figure>

            Entities like medical device companies and combination product manufacturers must complete post-market surveillance to monitor FDA-regulated items after clearance.\n<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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            POST MARKET SURVEILLANCE (PMS)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            \n\t\t\t\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
            \n\t\t\t\t
            \n\t\t\t\t\t\t\t

            Monitor the performance of a product with a collection of post-market processes and activities.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

            \n\t\t\t\t
            \n\t\t\t\t\t\t\t
            • Complaint Handling<\/li>
            • Recall Crisis Management<\/li>
            • Adverse Event Reporting<\/li>
            • Post Market Surveillance Activities<\/li>
            • Post Market Clinical Follow-up Studies (PMCF)<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
              \n\t\t\t\t
              \n\t\t\t\t\t
              \n\t\t\t
              <\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
              \n\t\t\t\t\t\t
              \n\t\t\t\t\t
              \n\t\t\t
              \n\t\t\t\t\t\t\t\t
              \n\t\t\t\t
              \n\t\t\t\t\t
              \n\t\t\t
              <\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
              \n\t\t\t\t
              \n\t\t\t

              REMEDIATION ACTIVITIES<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
              \n\t\t\t\t
              \n\t\t\t\t\t
              \n\t\t\t\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
              \n\t\t\t\t
              \n\t\t\t\t\t\t\t

              Implement a plan to define <\/span>remediation<\/span> activities, determine risk, discover root cause and design corrective actions following <\/span>warning letters<\/span>, <\/span>audits<\/span> (internal, <\/span>FDA<\/span> or <\/span>regulatory<\/span> bodies) or gap <\/span>assessments<\/span>.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

              \n\t\t\t\t
              \n\t\t\t\t\t\t\t
              • QMS – Quality Management System<\/li>
              • DHF – Design History File<\/li>
              • Technical Documentation – Technical File, Design Dossier, STED<\/li>
              • 510 (k) Catch Up and Assessment<\/li>
              • Quality Plan and Associated Risk<\/li>
              • Root Cause and CAPA<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
                \n\t\t\t\t
                \n\t\t\t\t\t
                \n\t\t\t
                <\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
                \n\t\t\t
                \n\t\t\t\t\t\t\t\t
                \n\t\t\t\t
                \n\t\t\t
                \"\"<\/figure>

                We offer the Right Path, Right Now\u00ae to ensure a quality plan to define remediation activities, root causes, and corrective actions as well as risk during remediation activity.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

                \n\t\t\t\t
                \n\t\t\t\t\t
                \n\t\t\t
                <\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

                Regulatory Consulting & Strategy Services We\u2019re more than just an FDA compliance consultant! At A Wright Path, we view our clients as business partners and work with you to develop strategies that best benefit your business. Our partnership is built on excellence, integrity, passion and social conscience. As your business partners, we stay abreast of […]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":[],"yoast_head":"\nFDA Regulatory Compliance Consulting & Quality Management<\/title>\n<meta name=\"description\" content=\"A Wright Path isn\u2019t just an FDA compliance consultant; we\u2019re a partner for regulatory affairs, quality assurance, continuous improvement and more!\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/awrightpath.net\/our-services\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Regulatory Compliance Consulting & Quality Management\" \/>\n<meta property=\"og:description\" content=\"A Wright Path isn\u2019t just an FDA compliance consultant; we\u2019re a partner for regulatory affairs, quality assurance, continuous improvement and more!\" \/>\n<meta property=\"og:url\" content=\"https:\/\/awrightpath.net\/our-services\/\" \/>\n<meta property=\"og:site_name\" content=\"A Wright Path | Right Path. 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