Strategies built on deep-rooted Regulatory & Quality expertise
Years of experience in the Quality and Regulatory domains enable us to anticipate regulatory challenges and proactively implement quality measures that meet compliance requirements, enhance product performance, and prioritize patient safety.
Regulatory Solutions
We navigate the regulatory landscape and deliver the tactical execution so you can focus on what you do best: delivering world-class MedTech innovations.
Regulatory Strategies, Regulatory Landscape Assessment
Prepare US/OUS Submissions:
Pre-Submission
510(k)
IDE
PMA
De Novo
Breakthrough Designation
CE Mark Technical File
Notice of Change
STED
Submission Response Strategy (AINN Response)
Clinical Evaluation Report (CER)
Gap Analysis to Regulatory Standards
Represent Clients in Meetings with Regulatory Agencies
Advertisement and Promotion Review
Interim Regulatory Leadership
Regulatory Project Management
Quality Management Systems
Solutions designed for compliance and tailored to your specific needs.
Establish, refine, scale, Quality Management System (QMS)
Establish, refine Quality Management System (QMS)
Represent Quality function for Design Control, Risk Management activities
Remediation for Audit Findings and Warning Letters
Represent company during FDA inspections, Notified Body audits, MDSAP audits
Perform internal, supplier, economic operator, mock FDA, EU MDR, IVDR, MDSAP, audits
Support Recall, Field Safety Corrective Action Execution
Review Quality Management System documentation for compliance
Quality Management System Training to external and internal standards and procedures.
FAQ
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RAQA Consulting provides expertise in Regulatory Affairs and Quality Assurance to help companies navigate complex regulations and ensure compliance. This support helps you streamline product development, avoid costly regulatory pitfalls, and achieve successful market entry and sustainability.
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We work with companies across various sectors, including MedTech, pharmaceuticals, biologics, biotechnology, lab testing, and sterile compounding. Our services are tailored to meet the unique regulatory and quality needs of each industry.
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We stay up-to-date with the latest FDA guidelines and use our extensive experience to implement and manage compliance strategies. This includes preparing and submitting regulatory filings, conducting audits, and providing ongoing support to ensure that your products meet all regulatory requirements.
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During a regulatory audit, our team will assist you in preparing and organizing necessary documentation, ensuring that all processes comply with regulations. We help address any findings or concerns and provide guidance on corrective actions to maintain compliance.
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Our consulting services help you navigate regulatory requirements and approvals to bring your products to market efficiently. We provide strategic guidance on regulatory pathways, submission preparation, and quality management systems to ensure a smooth market entry.
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Common challenges include keeping up with changing regulations, managing complex documentation requirements, and addressing non-compliance issues. Our team helps mitigate these challenges through expert guidance and proactive management.
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If you receive a non-compliance letter from the FDA, it’s important to address it promptly and thoroughly. Start by reviewing the letter to understand the specific issues identified. Work with your RAQA consultant to develop a detailed response plan, including corrective and preventive actions to resolve the issues. Implement the necessary changes and provide evidence of compliance in your response to the FDA. Our team can assist you in preparing a comprehensive response and guiding you through the process to ensure that your corrective measures meet regulatory expectations.
