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)
ASELL LLC
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
Advisory and execution support for regulatory strategy, preparation of regulatory submissions, and facilitation of agency interactions for medical devices and diagnostics.
Design and implementation of scaled QMS under FDA QSR and ISO 13485, including SOPs, quality manuals, training, and audit readiness.
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 roadmap creation, program management, risk management, and partner/vendor oversight to balance technical, regulatory, quality, schedule and budget constraints.
Identification of federal funding opportunities, capture planning, proposal development, subcontracting support, and execution support for federally funded programs.
Advisory and execution support for regulatory strategy, preparation of regulatory submissions, and facilitation of agency interactions for medical devices and diagnostics.
Design and implementation of scaled QMS under FDA QSR and ISO 13485, including SOPs, quality manuals, training, and audit readiness.
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 roadmap creation, program management, risk management, and partner/vendor oversight to balance technical, regulatory, quality, schedule and budget constraints.
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
News & Updates
A workshop focused on radiological/nuclear emergency response capabilities, featuring ASELL’s Chief Scientist presenting on biodosimetry diagnostics.
A workshop hosted by RITN on radiological/nuclear emergency preparedness, with ASELL’s Dr. Kowalski presenting on biodosimetry tools.
A discussion with top medtech experts on the upcoming FDA Quality System Regulation (QSR) draft, its implications, and industry perspectives.
An article discussing the challenges faced by the medical device industry and FDA during the COVID-19 pandemic, especially regarding EUA processes.
Guidance on regulatory considerations for developers of SARS-CoV-2 direct detection tests, emphasizing sensitivity, specificity, and EUA requirements.
Information on regulatory considerations for serology test developers, including accuracy, sensitivity, specificity, and FDA EUA data.
A workshop focused on radiological/nuclear emergency response capabilities, featuring ASELL’s Chief Scientist presenting on biodosimetry diagnostics.
A workshop hosted by RITN on radiological/nuclear emergency preparedness, with ASELL’s Dr. Kowalski presenting on biodosimetry tools.
A discussion with top medtech experts on the upcoming FDA Quality System Regulation (QSR) draft, its implications, and industry perspectives.
An article discussing the challenges faced by the medical device industry and FDA during the COVID-19 pandemic, especially regarding EUA processes.
Guidance on regulatory considerations for developers of SARS-CoV-2 direct detection tests, emphasizing sensitivity, specificity, and EUA requirements.
Information on regulatory considerations for serology test developers, including accuracy, sensitivity, specificity, and FDA EUA data.