Strategic Consulting for Diagnostics, Precision Medicine & FDA Innovation
From regulatory strategy and FDA submissions to precision medicine, diagnostics, and commercialization, we help life science organizations accelerate innovation with confidence.
Our Services
Comprehensive Solutions
Regulatory Strategy Development
Regulatory strategy planning, regulatory risk analysis, de-risking strategies for drug and diagnostic development and approvals
Least burdensome approaches for adaptability and flexibility
Strategies for biomarker identification, validation, CDx testing and patient selection in clinical trials
Balancing innovation with business objectives and harmonizing innovation with strategic goals
Regulatory Support for FDA Submissions
Support in preparation of Q-subs, Breakthrough Device Designation requests, 510(k)s, PMAs, PMA supplements, De Novo submissions, PCCPs, IDEs
Mock review of FDA submissions and pressure testing ideas
Effective project management
IVD and CDx Development Support
Comprehensive support in selection of sampling approaches, preparation of analytical and clinical validation plans, study protocols and reports, data development plans
Strategic guidance and pivoting tailored approaches for analytical validation and clinical evidence generation for liquid-biopsy and tissue-biopsy based assays
Product development under design control utilizing a phase-gated approach, with defined milestones
Diagnostic Technologies Across Disease Areas
Specialized in IVDs/LDTs across various disease areas including oncology, neurology, infectious diseases, rare diseases, toxicology, pharmacogenomics, STI, women's health
Strong expertise in genomics, proteomics, molecular, cellular, and protein-based assays
Proficient in digital biomarkers, digital pathology, AI/ML enabled novel clinical diagnostics, and SiMD & SaMD
Market Segmentation and Analysis
Market intelligence, market trend and competitive landscape analysis
Support high complexity CLIA clinical labs and IVD manufacturers for Point of Care (PoC), OTC/DTC, at-home tests and at-home sample collection kits, IVDs offered as single-site LDT tests, and distributed kit models for decentralized testing
Adapting strategies to diverse market segments and intended use settings
Integrating Precision Medicine & Genomic Testing
Strategic planning for biomarker strategy and technology assessment
Support for the integration of genomic testing approaches into the existing clinical processes and healthcare settings
Data & cloud strategies for large-scale genomic and clinical data
Due-diligence of technologies, companies, and precision medicine initiatives for market potential
Market development support for opportunities in the precision medicine space
Quality Management System Implementation
Guidance and support to build Quality Management System (QMS) in compliance with 21 CFR 820 and ISO 13485
Conducting comprehensive gap analysis and implementing remediation strategies for clinical diagnostic laboratories transitioning from CLIA/CAP regulations to FDA regulatory compliance under FDA's new LDT rule, ensuring adherence to quality standards and requirements
Here's how we work
Assess
Understand your science, goals, and regulatory landscape.
→
Develop
Build a practical strategy aligned with business and regulatory objectives.
→
Execute
Support submissions, implementation, commercialization, and long-term success.
Industries We Support
Biotechnology
Diagnostics
Pharmaceutical
Medical
Devices
Digital
Health
Precision
Medicine
Healthcare
Systems
Life Science Investors
Industries We Support
Biotechnology
Diagnostics
Pharmaceutical
Medical
Devices
Digital
Health
Precision
Medicine
Healthcare
Systems
Life Science Investors
Here's how we work
Assess
Understand your science, goals, and regulatory landscape.
Develop
Build a practical strategy aligned with business and regulatory objectives.
Execute
Support submissions, implementation, commercialization, and long-term success.
Industries We Support
Biotechnology
Diagnostics
Pharmaceutical
Medical Devices
Digital Health
Precision Medicine
Ready to Partner for Regulatory Strategies and Diagnostic Solutions?
Schedule a free consultation to discuss your needs and discover how we can help you thrive.
Expert Consulting from Concept to Commercialization in Precision Medicine
Our Services
Regulatory Strategy Development
Regulatory Support for FDA Submissions
IVD and CDx Development Support
Diagnostic Technologies Across Disease Areas
Market Segmentation and Analysis
Integrating Precision Medicine & Genomic Testing
Quality Management System Implementation
(301) 919-8573
(301) 919-8573
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