ASELL partners and collaborates with developers to strengthen global health and emergency preparedness. We provide integrated approaches that allow our partners to access non-dilutive funding and focus on their core commercial markets. With extensive expertise in medical device development, ASELL has the core competencies needed to advance technology from early-stage concept through product delivery. Our team brings deep experience in quality management, regulatory affairs, clinical research, and product development. Please contact us if you would like to explore how we might work together.

Regulatory Affairs

Many of the technologies we develop are medical devices that fall under federal regulatory oversight. A successful regulatory submission is essential in moving a medical device to market. ASELL has expertise in regulatory affairs from the initial development of regulatory strategies through post marketing support. We routinely prepare submission materials and interact with FDA. Our team includes former FDA personnel and understands the complexity of the regulatory paths across a wide breadth of medical devices.

Our experiences include:

  • Development of Regulatory Strategy
  • Q-Submissions and FDA Engagement
    • Q-Submission preparation/review
    • Meeting preparation/participation
  • Submission Preparation
    • Emergency Use Authorization
    • Breakthrough Device Designation
    • 510(k), de novo, PMA

Quality Management

To achieve our product development objectives, ASELL operates under an FDA compliant quality management system (QMS). A structured quality management system is critical to achieving and maintaining regulatory clearance for any medical device. Some of our partners and collaborators also have established QMSs, but many do not. As needed to meet shared objectives, ASELL provides quality management system support including:

  • Development and Implementation of an appropriately scaled Quality Management System under FDA’s Quality System Regulations and ISO 13485
  • Quality Manual and SOP development
  • QMS Training
  • Audits
    • Internal Audits
    • Supplier Audits
    • External Audit Prep

Clinical Research

From early-stage feasibility testing through device validation, clinical studies are integral to the development of in vitro diagnostics. Since its inception, ASELL has executed clinical research ranging from small studies to demonstrate proof-of-concept through the pivotal clinical studies required to support regulatory submittal. Our team brings proven experience across the disciplines needed to successfully conduct clinical studies including:

  • Clinical Study project management
  • Study design, protocol development and review
  • IRB submissions and amendment management
  • Site and lab management
    • Identification and selection
    • Qualification and training
    • Monitoring
  • Trial Master File creation
  • Data management, analysis and reporting
  • Usability testing
  • Clinical performance testing from feasibility through validation

Product Development

At our core, we are a product and solutions development company. Our team has developed a broad range of diagnostic and detection technologies to address healthcare and national security challenges. Our primary focus is developing medical devices to increase health security preparedness. Successful development of a medical device demands more than great science and engineering. It requires achieving technical objectives within a framework of quality management and regulatory requirements, all within schedule and budget constraints. ASELL’s team of experienced product development managers have a proven track record of developing and implementing plans that balance these requirements. Our team addresses all elements of technology development such as:

  • Product Roadmap and Development Planning
  • Program Management
  • Risk Management
  • Partner and Vendor Management
  • Scientific Advice and Support

Government Contracting

The US government invests billions of dollars annually in technology development, including non-dilutive funding for detection technologies and medical devices. The complexities of identifying specific funding opportunities, engaging the government agencies, generating a successful proposal, and executing a federally funded program can be daunting to many. ASELL’s roots are in government contracting, and we have the requisite expertise to navigate the federal landscape and work with our partners to leverage federal dollars to advance technologies.

We collaborate with our partners in:

  • Identifying funding targets
  • Federal client outreach
  • Capture planning
  • Proposal development
  • Federal contracting and subcontracting
  • FAR compliant accounting system

Learn More About ASELL