Specialized expertise in harmonizing pharmaceutical cGMP requirements with medical device QMS for combination products.

Full-cycle QMS establishment for device manufacturers and combination product developers, from gap analysis through certification-ready documentation and mock audits.

Integrated complaint handling, CAPA systems, and adverse event reporting that satisfy both FDA device (21 CFR Part 803/806) and pharma (21 CFR Part 314/600) requirements simultaneously.

EU MDR Article 117 compliance programs designed by former Notified Body auditors, ensuring Technical Documentation aligns with EU MDR Annex I Genneral and Safety Performance Requirements

Rapid response to FDA 483 observations, Warning Letters, or Notified Body Major Non-Conformities with root cause analysis, corrective action plans, and implementation support that close findings permanently.