Multinational IVD Compliance: Scalable Regulatory Intelligence for Multi-Country Submissions

Discover how a German-based global healthcare innovator tackled the regulatory complexities of launching multiple in vitro diagnostic devices (IVDs) across Canada, Turkey, and Brazil. With a diverse portfolio targeting various medical needs, including viral and respiratory infections and asthma management, the client faced numerous challenges. Our Regulatory Intelligence services offered critical insights, supporting the client's strategic market expansion.

• The client required rapid turnaround times for Regulatory Intelligence on multiple IVDs intended for professional and personal use.
• Regulatory guidelines in Turkey and Brazil posed a linguistic barrier as they were available only in local languages, complicating the compliance process.
• Limited availability of reliable regulatory information in some target markets created further challenges in understanding and meeting local requirements.
• The client needed detailed, market-specific regulatory data to inform the registration and launch strategy for their IVDs across diverse regions.