Commercialization
During the commercialization phase, focus shifts to scaling distribution (if necessary), securing market access, and maintaining compliance with FDA, CLIA, state, and other regulatory requirements to ensure reliable performance in real-world settings.
Product Launch Readiness
A critical element of successful product launch readiness is ensuring your Quality Management System (QMS) is fully built out and compliant. This includes conducting pre-production GMP audits, auditing the Design History File (DHF) or project file, establishing robust complaint handling and adverse event reporting procedures, and developing and executing a comprehensive product launch review.
Registration and Listing
Several markets have registration and listing requirements for organizations and their IVDs in order for them to be commercialized. We can help you navigate these requirements and prepare the necessary submissions to ensure compliance.
GUDID Support
In addition to registration and listing, in the US companies also need to comply with the GUDID submission requirements. We can help you understand these requirements and submit on your behalf.
Import/Export Support
If your commercialization strategy includes importing or exporting IVDs, we can help you navigate FDA and other regulatory requirements to ensure smooth border clearance and avoid costly delays or rejections.
Ad Promo/Labeling Support
Our team can review your advertising materials and labeling to ensure that all claims are compliant and appropriately substantiated, reducing the risk of regulatory scrutiny. We also help establish internal review processes that engage the right stakeholders, supporting consistent, appropriate and compliant approval workflows and minimizing the risk of enforcement actions.