Services Validation-Launch-Support
From Validation to Market Success
Complete support for platform validation, regulatory approval, and commercial launch
SpeeDx brings over 15 years of experience successfully validating molecular diagnostic assays across multiple PCR platforms and navigating complex regulatory pathways worldwide. Our validation and launch support services de-risk your commercialization journey, accelerating time-to-market while ensuring regulatory compliance and commercial readiness.
From analytical validation through clinical studies to regulatory submissions and market launch, we provide the technical expertise, regulatory knowledge, and commercial infrastructure that transforms your diagnostic innovation into a market-ready product.
Whether you're a diagnostic company preparing for FDA submission, a healthcare system implementing new testing protocols, or a research organization commercializing a novel assay, SpeeDx provides comprehensive support tailored to your specific validation and launch requirements.
Our multi-disciplinary team has achieved regulatory approvals across FDA (USA), CE-IVD (Europe), TGA (Australia), Health Canada, and MDSAP certification—successfully bringing 50+ products to market globally.
Platform Validation
Leverage our expertise validating assays across industry-leading PCR platforms:
Analytical performance verification
Clinical validation studies
Cross-platform concordance testing
Workflow optimization
Automation integration
Quality system documentation
Successfully validated on Applied Biosystems™ 7500 Series, QuantStudio™ Systems, Bio-Rad CFX96™ and CFX384™, Roche LightCycler® Systems, and custom platforms.
Regulatory & Launch
Navigate regulatory pathways and accelerate market entry:
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FDA 510(k) and De Novo submission support
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CE-IVD technical documentation
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TGA and Health Canada applications
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MDSAP certification guidance
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Clinical evidence generation
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Reimbursement strategy
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KOL engagement programs
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Commercial launch planning
From Validation to Launch
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Applied Biosystems™ 7500 Series
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QuantStudio™ Systems
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CFX96™ and CFX384™
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LightCycler® Systems
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Custom platforms
Platform Coverage
Analytical performance
Clinical validation
Cross-platform concordance
Workflow optimization
Automation integration
Validation Scope
FDA submission preparation
CE-IVD documentation
TGA applications
Health Canada submissions
Country-specific requirements
Regulatory Support
Multi-Platform Validation Expertise
Transform Your Laboratory Economics
Proven Global Track Record
SpeeDx has successfully navigated regulatory pathways across all major jurisdictions, achieving approvals for 50+ molecular diagnostic products. Our deep experience with FDA, CE-IVD, TGA, Health Canada, and MDSAP certification processes ensures your product meets the highest quality and compliance standards for global market access.
Working with partners ranging from multinational diagnostic companies to emerging innovators, we've established validation and launch frameworks that reduce risk, accelerate timelines, and ensure commercial success.
*For research use only. Not for use in diagnostic procedures.
Regulatory Approvals Achieved
- FDA clearance (USA)
- CE-IVD certification (Europe)
- TGA approval (Australia)
- Health Canada authorization
- MDSAP certification
Regional Partners
- North America: Labcorp, Quest
- Europe: Multiple distributors
- Asia-Pacific: Established network
- Middle East & Africa: Growing presence
Market Presence
- 100+ direct customers globally
- 1000s of customers via partners
- Active in 40+ countries
- Influenced international clinical guidelines
Ready to Transform Your Diagnostic Capabilities?
SpeeDx offers the technology, expertise, and partnership models to accelerate your diagnostic success. Whether you need:
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Technology licensing for competitive advantage
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Custom assay development for unique needs
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Co-development partnerships for innovation
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Validation and launch support for market entry