ASELL LLC
ASELL turns science into solutions by developing and delivering cutting edge technology solutions that strengthen the world’s health security and emergency preparedness. With deep expertise in medical device development, clinical diagnostics, regulatory affairs, quality assurance, biodosimetry, and government contracting, ASELL’s team of experts advance technologies from early-stage development through product delivery. They partner and collaborate with developers to advance technologies to strengthen global health and emergency preparedness, offering services including regulatory and quality advisory, clinical studies, government program support, and product development support.
Industries
Nr. of Employees
small (1-50)
Products
Triage biodosimetry system (hematology-based triage)
A triage-stage diagnostic system that uses hematological data and biodosimetry algorithms to rapidly identify individuals who require further testing or acute medical care after radiological/nuclear exposure.
High-throughput confirmatory biodosimetry system (CBMN-based)
A high-throughput implementation of the cytokinesis-block micronucleus (CBMN) cytogenetic assay adapted and automated to provide quantitative biodosimetry results suitable for large-scale radiological/nuclear incident response.
Triage biodosimetry system (hematology-based triage)
A triage-stage diagnostic system that uses hematological data and biodosimetry algorithms to rapidly identify individuals who require further testing or acute medical care after radiological/nuclear exposure.
High-throughput confirmatory biodosimetry system (CBMN-based)
A high-throughput implementation of the cytokinesis-block micronucleus (CBMN) cytogenetic assay adapted and automated to provide quantitative biodosimetry results suitable for large-scale radiological/nuclear incident response.
Services
Regulatory affairs consulting
Advisory and execution support for regulatory strategy, preparation of regulatory submissions, and facilitation of agency interactions for medical devices and diagnostics.
Quality management system implementation
Design and implementation of scaled QMS under FDA QSR and ISO 13485, including SOPs, quality manuals, training, and audit readiness.
Clinical research and study execution
End-to-end clinical study services for diagnostics including protocol development, IRB management, site and lab management, monitoring, TMF creation, data management, and reporting.
Product development and program management
Product roadmap creation, program management, risk management, and partner/vendor oversight to balance technical, regulatory, quality, schedule and budget constraints.
Government contracting and capture support
Identification of federal funding opportunities, capture planning, proposal development, subcontracting support, and execution support for federally funded programs.
Regulatory affairs consulting
Advisory and execution support for regulatory strategy, preparation of regulatory submissions, and facilitation of agency interactions for medical devices and diagnostics.
Quality management system implementation
Design and implementation of scaled QMS under FDA QSR and ISO 13485, including SOPs, quality manuals, training, and audit readiness.
Clinical research and study execution
End-to-end clinical study services for diagnostics including protocol development, IRB management, site and lab management, monitoring, TMF creation, data management, and reporting.
Product development and program management
Product roadmap creation, program management, risk management, and partner/vendor oversight to balance technical, regulatory, quality, schedule and budget constraints.
Government contracting and capture support
Identification of federal funding opportunities, capture planning, proposal development, subcontracting support, and execution support for federally funded programs.
Expertise Areas
- Regulatory compliance for medical devices and in vitro diagnostics
- Quality management systems (FDA QSR, ISO 13485)
- Clinical trial design and clinical study management for diagnostics
- Biodosimetry and radiological/nuclear preparedness
Key Technologies
- In vitro diagnostics (IVD)
- Cytokinesis-block micronucleus (CBMN) assay automation
- Cytogenetic biodosimetry
- RT-qPCR and molecular diagnostics