• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Blog
  • News & Events
  • Videos
main-logo-small

Compliance Architects

Consulting Technology Outsourcing

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

REMS (Risk Evaluation and Mitigation Strategies)

Compliance Architects® is a proven partner in REMS audit services, and offers custom-tailored solutions to suit each client.

REMS audits are significantly different than”typical” site audits. Due to the complexity, requirements, and number of parties involved, REMS audits require an agile approach, which Compliance Architects® has shown continued success in delivering.

FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements to ensure the drug’s health benefits outweigh the risks for patients. Inspections are prioritized using a risk-based approach.

The agency will take action if issues found during the REMS inspections are not promptly and adequately corrected. Failure to comply with REMS requirements may result in enforcement action such as product seizure, injunction or civil money penalties.

FDA also reviews REMS assessment reports to evaluate compliance with legal and regulatory requirements. The agency takes appropriate regulatory action for noncompliance, which may include warning letters or untitled letters, to address serious safety concerns and mitigate risks to patients.

Don’t risk noncompliance! Get in touch with the REMS experts now!

 

Primary Sidebar

I Would Like Compliance Architects® to Contact Me Regarding REMS Audit Services

Email Consent*

Footer

Compliance Architects®

  • Contact Us
  • (888) 734-9778
  • info@compliancearchitects.com

Quick Links

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

Our Services

  • Inspection Readiness & Enforcement
  • FDA Quality Consulting – Systems and Training
  • Quality Assurance and Engineering
  • Corporate Compliance and Litigation Services
  • FDA Regulatory Consultants – Due Diligence
  • Quality, Compliance, Regulatory & Operations’ Staffing Services

Proprietary Solutions

  • Writing for Compliance®
  • Quality Pulse®
  • CRPN Quality Roadmap®

© 2009-2022 Compliance Architects Holdings LLC – used by permission. All copyrights, trademarks and other intellectual property are the property of Compliance Architects Holdings LLC and are used by permission.

  • Debarment Certification Statement
  • Privacy Policy
  • Terms of Use

Contact Us Today