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NAVIGATING THE COMPLEXITY OF CDX DEVELOPMENT
Companion diagnostics are the cornerstone of precision medicine, but the path to approval is fraught with challenges. From evolving FDA regulatory frameworks to the stringent requirements of the EU IVDR, the compliance landscape is constantly shifting. We bridge the gap between clinical science and regulatory strategy, ensuring your diagnostic development never slows down your therapeutic timeline.
KEY SERVICE
Regulatory Affairs
FDA PMA, 510(k), EU IVDR compliance strategy.
Quality & Compliance
QMS setup (ISO 13485), risk management.
Clinical Development
CRO services, clinical trial design for CDx, site management.
Market Access
Reimbursement strategy, commercialization planning.
PROVEN TRACK RECORD
Successfully guided 20+ CDx products to FDA approval.
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