Ensuring Compliance, Enabling Success
NovintiX provides comprehensive quality and regulatory consulting services to help life sciences companies meet the highest standards of compliance. Our experienced team understands the complexities of global regulatory requirements and helps you navigate them efficiently.
Our Services Include:
- Quality Management Systems - QMS design, implementation, and optimization
- Regulatory Strategy - Global regulatory planning and submission support
- Audit Readiness - Preparation for FDA, EU MDR, and ISO audits
- CAPA Management - Corrective and preventive action systems
- Risk Management - ISO 14971 compliance and risk assessment
- Post-Market Surveillance - Vigilance, complaint handling, and MDR reporting
Regulatory Expertise
Our team has extensive experience with:
- FDA 21 CFR Part 820, 210/211
- EU MDR and IVDR
- ISO 13485 and ISO 9001
- Health Canada and international regulations