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RQMIS

Additional Services

Our Comprehensive Additional Services Include:

1. Dietary Supplement Audits

  • Conduct thorough audits to ensure compliance with FDA regulations (21 CFR Part 111).
  • Identify and address gaps in quality management systems (QMS).
  • Provide actionable recommendations for continuous improvement and regulatory adherence.

2. Adverse Event Reporting

  • Develop and manage adverse event reporting systems to ensure timely and accurate submissions to regulatory authorities.
  • Assist with compliance for FDA (21 CFR Part 803) and international reporting standards.
  • Provide trend analysis and root cause evaluations to mitigate recurring events.

3. Recalls

  • Create and implement recall strategies in compliance with regulatory requirements.
  • Manage communication with regulatory authorities and stakeholders.
  • Guide clients through product retrieval, reporting, and resolution processes.

4. Corrective and Preventive Action (CAPA)

  • Establish CAPA processes that comply with ISO 13485 and 21 CFR Part 820.
  • Investigate root causes of nonconformities and implement preventive measures.
  • Track and validate the effectiveness of CAPA actions to prevent recurrence.

5. Integrating Quality Systems and Regulatory Submissions

  • Develop integrated QMS frameworks to align with ISO 13485, FDA QSR (21 CFR Part 820), and global standards.
  • Support in preparing and submitting regulatory documentation for product approvals.
  • Ensure alignment between QMS practices and regulatory requirements.

6. Risk Management System Design

  • Design and implement risk management systems aligned with ISO 14971 and regulatory guidelines.
  • Provide risk assessments, failure mode analysis (FMEA), and mitigation strategies.
  • Ensure risk management is integrated into product lifecycle processes.

7. Managing Risk

  • Conduct comprehensive risk assessments for products, processes, and supply chains.
  • Develop risk control strategies tailored to your operational needs.
  • Provide ongoing monitoring and reporting of risk management effectiveness.

8. Vigilance and Medical Device Reporting (MDR) (21 CFR 803)

  • Ensure compliance with MDR regulations (21 CFR Part 803) and international vigilance requirements.
  • Manage reporting systems for adverse events and serious incidents.
  • Provide analysis and documentation to meet regulatory timelines and standards.

9. Training Programs

  • Deliver training programs on:
    • Risk Management (ISO 14971)
    • Quality Management Systems (ISO 13485)
    • FDA QSR (21 CFR Part 820)
    • Adverse Event Reporting (21 CFR 803)
  • Equip teams with practical knowledge and compliance skills.

10. Temporary Regulatory, Clinical, and Quality Management Support

  • Provide on-demand professionals for temporary roles in regulatory, clinical, and quality management.
  • Ensure uninterrupted support during peak workload periods or resource transitions.
  • Offer expertise tailored to short-term or project-specific needs.

11. Design and Hire Regulatory, Clinical, and Quality Departments

  • Assist in structuring regulatory, clinical, and quality teams aligned with business goals.
  • Support recruitment, onboarding, and training of key personnel.
  • Develop job descriptions, performance metrics, and departmental workflows.

12. Business Acquisition and Due Diligence

  • Conduct regulatory and quality due diligence during mergers, acquisitions, and business expansions.
  • Assess compliance risks, operational gaps, and potential liabilities.
  • Provide detailed audit reports and strategic recommendations.

Why Choose RQMIS?

  • Proven Expertise: Decades of experience across medical devices, pharmaceuticals, dietary supplements, and Cannabis industries.
  • Customized Solutions: Tailored strategies to meet your unique operational and compliance needs.
  • Global Regulatory Insight: Expertise in navigating FDA, EU MDR, ISO, and international standards.
  • End-to-End Support: From initial assessments to ongoing compliance monitoring, we are your trusted partner at every step.

Partnering with RQMIS means gaining access to a dedicated team of experts committed to ensuring regulatory compliance, minimizing risk, and fostering sustainable growth for your business.

Let’s create a strategic path to success together.