IVD and CDx Regulatory Affairs Consulting
Providing global regulatory support for diagnostics across the assay development lifecycle.
Precision for Medicine’s IVD Regulatory Consulting Team has over 100 years of cumulative industry experience in In Vitro Diagnostics (IVDs), instruments (software and hardware), and specimen collection devices. Our experts offer comprehensive regulatory planning and strategy for all types of IVDs and Companion Diagnostics (CDx) across all scientific methodologies and therapeutic areas. We design and execute on regulatory solutions to facilitate global clinical trial assay testing and registrations in the United States, Canada, European Union, United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Japan, and Australia, among others.
Diagnostic regulatory support, from bench to bedside
Bringing a product from development to market can be challenging to navigate, which is why it is crucial to have a team of experts who know the ins and outs of the development life cycle for your diagnostic or Companion Diagnostic (CDx). Our team of In Vitro Diagnostic (IVD) Regulatory Affairs experts are ready to walk you step-by-step through these processes and guarantee to streamline the path to success for your IVD product.
200
IVD and CDx Presubmissions, IDEs, ITAs, and Annex XIV Submissions
250
510(k), Special 510(k)s, EUAs, De novos, PMAs, PMA supplements for IVD and CDx submissions in the US
We support the transition of laboratory developed tests (LDTs) to IVDs through the 510(k), de novo, or PMA pathways.
Our experts develop customized regulatory roadmaps, clinical trial enabling submissions, analytical and clinical trial designs, and regulatory submissions for commercialization of kit-based IVDs and CDx.
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Assay Development and Regulatory Strategy
- Global Regulatory Strategy and Roadmap Development
- Product Design Considerations
- Regulatory Pathway Identification
- Predicate Device Identification
- GAP Analysis for CLIA to CLSI
- Biomarker Definition
Assay Development and Regulatory Strategy
- Global Regulatory Strategy and Roadmap Development
- Product Design Considerations
- Regulatory Pathway Identification
- Predicate Device Identification
- GAP Analysis for CLIA to CLSI
- Biomarker Definition
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Assay Validation, Preclinical Submissions, and Evidence Collection
- Development of Analytical, Clinical, Flex, and User Study Designs
- Risk Assessment and Study Risk Determination Q-Submissions
- Pre-IDE Q-Submissions, IDE Applications, and Presubmissions
- Annex XIV Submissions
- Early Agency Meetings
- Bridging Strategies
- CDx Partner Qualification and Vetting
Assay Validation, Preclinical Submissions, and Evidence Collection
- Development of Analytical, Clinical, Flex, and User Study Designs
- Risk Assessment and Study Risk Determination Q-Submissions
- Pre-IDE Q-Submissions, IDE Applications, and Presubmissions
- Annex XIV Submissions
- Early Agency Meetings
- Bridging Strategies
- CDx Partner Qualification and Vetting
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Timely Regulatory Approval
- 510(k), Special 510(k), EUA, De Novo, PMA and PMA Supplement Submissions
- IVDR compliant Technical File Documentation
- Breakthrough Device Designations
- Compliance With UK MDR 2022 and UKCA Mark Approvals
- Global Registration Filings
- Regulatory Agency and Notified Body communications
Timely Regulatory Approval
- 510(k), Special 510(k), EUA, De Novo, PMA and PMA Supplement Submissions
- IVDR compliant Technical File Documentation
- Breakthrough Device Designations
- Compliance With UK MDR 2022 and UKCA Mark Approvals
- Global Registration Filings
- Regulatory Agency and Notified Body communications
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Commercialization Planning
- Labeling/Advertising/Promotion
- BIMO and Notified Body Audit Preparation
- Registration and Listing
Commercialization Planning
- Labeling/Advertising/Promotion
- BIMO and Notified Body Audit Preparation
- Registration and Listing
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Product Launch & In-Market Support
- Postmarket Surveillance
- QMS Certification
- Product Life Cycle Management
- Product Updates and Supplementary Filings
Product Launch & In-Market Support
- Postmarket Surveillance
- QMS Certification
- Product Life Cycle Management
- Product Updates and Supplementary Filings
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With people across 70+ countries, Precision provides comprehensive services that streamline and accelerate IVD and CDx development at a global scale
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Biospecimens
Biospecimens and biospecimen services curated to advance precision therapeutic and diagnostic development.
Biospecimens
Biospecimens and biospecimen services curated to advance precision therapeutic and diagnostic development. -
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Companion Diagnostics
End-to-end expertise to carry you from biomarker signature identification to timely regulatory approval.
Companion Diagnostics
End-to-end expertise to carry you from biomarker signature identification to timely regulatory approval. -
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Custom Assays
Precision offers exceptional scientific depth to support the development of de novo assays, with a particular specialization in cell-based assays and epigenetic immune cell phenotyping using our proprietary and patented Epiontis ID platform.
Custom Assays
Precision offers exceptional scientific depth to support the development of de novo assays, with a particular specialization in cell-based assays and epigenetic immune cell phenotyping using our proprietary and patented Epiontis ID platform.
