Remediation
Our experts provide strategic, end-to-end support across all remediation activities, combining process validation, compliance alignment, and corrective actions post-regulatory findings with a proven playbook approach.
Trinzo’s remediation solutions go beyond technical fixes to embed quality ownership, drive continuous improvement, and support change management.
By aligning with global regulatory standards and fostering cultural competencies, we help medical device companies establish a culture of compliance and quality that withstands regulatory scrutiny in the US, EU, and beyond.
Compliance and Remediation
Trinzo’s offerings address essential quality needs, including process validation, GMP compliance, EU MDR/IVDR transition, and regulatory corrective actions. Our support in these areas ensures that your quality management and manufacturing processes not only meet industry standards but also support long-term business goals. With seamless project management as a standard, we deliver rapid, organised compliance support that protects your market position.
Process Validation
We provide full-lifecycle process validation solutions, from Installation Qualification (IQ) to Operational (OQ) and Performance Qualification (PQ), ensuring manufacturing consistency, product quality, and regulatory compliance at every critical stage. Our approach safeguards your operational integrity and supports sustained compliance across the process validation lifecycle.
Good Manufacturing Practice (GMP) Compliance
Our GMP services include audits, remediation, and best-practice implementation, ensuring compliance with FDA, EU, and global standards to streamline production and reduce quality risks.
EU MDR and IVDR Transition Support
Our expert team provides seamless guidance through the EU MDR and IVDR transition, conducting in-depth gap assessments, updating technical documentation, and implementing strategic compliance measures. We help you minimize disruption, reduce regulatory risk, and maintain market access, ensuring a smooth and efficient transition that meets all new regulatory demands with confidence.
Non-Compliance Remediation
Trinzo’s targeted Non-Compliance Remediation addresses issues like Form 483, Warning Letters, Consent Decrees, and Notified Body Observations. With tailored project management and execution, we help clients achieve compliance fast—mitigating risks and securing your business continuity.
Gap Assessment
Our regulatory and compliance gap assessments precisely identify compliance discrepancies, providing a clear, prioritized roadmap for corrective actions. This structured approach allows for targeted, cost-effective remediation that supports sustained compliance, mitigates risk, and strengthens regulatory readiness.
Agency Response
We provide comprehensive support in preparing clear, proactive responses to regulatory bodies such as the FDA, EMA, and other international health authorities. Our experts help you address regulatory inquiries, inspection findings, and compliance issues with well-documented, transparent responses, demonstrating your commitment to compliance and patient safety. Our approach ensures your organisation meets regulatory expectations and is seen as a reliable, proactive partner in regulatory compliance.
Remediation Strategy & Execution
Our remediation strategies provide sustainable, cost-effective corrective actions that embed compliance into daily operations, reducing future risks. With a focus on efficiency and guided by extensive industry experience, we deliver structured solutions that enhance operational resilience, streamline compliance processes, and minimize costs associated with non-compliance
Trinzo provide world-class solutions to resolve your remediation challenges.
Our team of international consultants are ready to ensure your organisation achieves compliance with global standards and regulations.