From regulatory strategy and FDA submissions to precision medicine, diagnostics, and commercialization, we help life science organizations accelerate innovation with confidence.

Strategic Consulting for Precision Medicine, Diagnostics & Regulatory 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

Global Regulatory & Precision Medicine Strategy Development

  • Strategic advisory on complex, combined drug-CDx clinical trials to seamlessly integrate global regulatory requirements

  • 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 & EU IVDR

  • Strategic planning for pre-market submissions and early-stage FDA programs, including Breakthroughs, Q-Subs, and PCCPs

  • Navigating complex Clinical Performance Study Applications (PSA) and clinical evidence requirements across European Member States

  • Conducting pressure-testing and rigorous mock reviews to anticipate and mitigate regulatory hurdles before filing

  • 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

  • Health-authority engagement strategy, meeting preparation and regulatory position development

IVD and CDx Development Support

  • Aligning therapeutic and CDx development timelines to prevent costly clinical trial delays

  • 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

  • Experience across IVD and biomarker technologies and multiple 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

Diagnostic Business Model & Regulatory Strategy

  • CLIA/IVD models

  • Centralized versus distributed testing

  • PoC/DTC/at-home approaches

  • Regulatory implications of market configuration

  • Competitive/regulatory landscape

Integrating Precision Medicine & Genomic Testing

  • Clinical-trial biomarker testing strategy and integration of exploratory, enrollment and companion-diagnostic testing across development programs

  • Strategic planning for biomarker strategy and technology assessment

  • Support for the integration of genomic testing approaches into the existing clinical processes and healthcare settings

  • 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 in accordance with CLIA/CAP regulations and FDA regulatory compliance, ensuring adherence to quality standards and requirements

Our Services

Comprehensive Solutions

Global Regulatory & Precision Medicine Strategy Development

  • Strategic advisory on complex, combined drug-CDx clinical trials to seamlessly integrate global regulatory requirements

  • 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 & EU IVDR

  • Strategic planning for pre-market submissions and early-stage FDA programs, including Breakthroughs, Q-Subs, and PCCPs

  • Navigating complex Clinical Performance Study Applications (PSA) and clinical evidence requirements across European Member States

  • Conducting pressure-testing and rigorous mock reviews to anticipate and mitigate regulatory hurdles before filing

  • 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

  • Health-authority engagement strategy, meeting preparation and regulatory position development

IVD and CDx Development Support

  • Aligning therapeutic and CDx development timelines to prevent costly clinical trial delays

  • 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

  • Experience across IVD and biomarker technologies and multiple 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

Diagnostic Business Model & Regulatory Strategy

  • CLIA/IVD models

  • Centralized versus distributed testing

  • PoC/DTC/at-home approaches

  • Regulatory implications of market configuration

  • Competitive/regulatory landscape

Integrating Precision Medicine & Genomic Testing

  • Clinical-trial biomarker testing strategy and integration of exploratory, enrollment and companion-diagnostic testing across development programs

  • Strategic planning for biomarker strategy and technology assessment

  • Support for the integration of genomic testing approaches into the existing clinical processes and healthcare settings

  • 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 in accordance with CLIA/CAP regulations and FDA regulatory compliance, 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.

Ready to Partner for Regulatory Strategies and Diagnostic Solutions?

Contact Blue Tulip to discuss your needs and discover how we can help you thrive.