Quality & Regulatory Compliance

Sanner supports submission planning, documentation, and agency engagement worldwide. Our Regulatory Affairs team helps reduce approval timelines, manage compliance risk, and ensure readiness for regulatory review.

• 510(k), De Novo, and PMA submissions
• CE Technical Files aligned with EU MDR 2017/745
• eCTD documentation for combination product filings
• Regulatory strategies aligned with FDA 21 CFR Part 820 and international standards
• Labeling and packaging support: sterile barrier systems, tamper-evidence, shelf-life validation
• Continuous monitoring of regulatory updates across markets

We align product development with regulatory requirements and quality expectations from the start. Our ISO 13485-certified quality system and traceability tools ensure consistent performance and documentation readiness at every stage.

• ISO 13485 and cGMP-compliant systems
• Standardized processes and audit-ready documentation
• PLM (Product Lifecycle Management) for controlled design transfer and lifecycle documentation
• MES (Manufacturing Execution System) for full traceability and real-time production tracking
• Risk-based processes and integrated quality controls
• Continuous improvement culture across global operations

Sanner supports device–drug combination product development with coordinated regulatory planning, submission support, and system alignment. Our in-house drug-handling capabilities and global quality systems ensure readiness for production and regulatory review.

• Regulatory planning and submission support
• eCTD content preparation for device constituent parts
• Serialization, labeling, and packaging planning
• Quality and compliance alignment for device–drug interfaces
• Engagement with FDA (US), EMA (EU), NMPA (CN), and other global agencies