OUR consulting Services

Regulatory Strategy Development

Regulatory Support for FDA Submissions

Regulatory Support for FDA Submissions

Regulatory strategy planning, regulatory risk analysis, de-risking strategies and least burdensome approaches for adaptability and flexibility including preparation of Pre-determined Change Control plans (PCCPs) and leveraging RWD/RWE and historical data
Balancing innovation with business objectives and harmonizing innovation with strategic goals

Regulatory Support for FDA Submissions

Regulatory Support for FDA Submissions

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

Regulatory Support for FDA Submissions

Diagnostic Technologies Across Disease Areas

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

Integrating Precision Medicine & Genomic Testing

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

Integrating Precision Medicine & Genomic Testing

Integrating Precision Medicine & Genomic Testing

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

Integrating Precision Medicine & Genomic Testing

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

Quality Management System Implementation

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