When compliance issues threaten your clinical trials, swift action is a must. We specialize in IVD, combination product, and medical device remediation studies that address regulatory findings, resolve compliance issues, and support your product’s journey to market.
With decades of experience and a team of former regulators, we provide the strategic guidance to turn challenges into opportunities and ensure your program’s long-term success.
Why Choose RQM+ for IVD, Combination, and Medical Device Remediation Studies?
Partnering with RQM+ for remediation studies delivers robust benefits, including:
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Targeted Compliance Solutions
Expert strategies tailored to address clinical trial-specific findings from global regulatory agencies.
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Trial Continuity Assurance
Minimize disruptions to your trial timeline with proactive remediation planning.
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Regulatory Alignment
Maintain full compliance with changing FDA, EU, and other international standards.
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Optimized Trial Outcomes
Ensure trial protocols, data integrity, and documentation meet regulatory expectations.
Core Services for Remediation
Our remediation study expertise addresses trial-specific challenges, including:
Expertise in FDA Warning Letters
Device-Specific Expertise
Looking for tailored solutions for your specific product type? Explore our dedicated pages:
Medical Device Remediation Experts
Regulatory challenges don’t have to derail your program. With RQM+ as your trusted remediation partner, you can confidently address compliance issues:
- Achieve regulatory clearance for products under consent decree
- Reduce your response timelines to regulatory findings
- Prevent repeat FDA observations