Arbit Consulting LLC and its affiliates offer a variety of services ranging from staff education, remote and in-person, to full regulatory strategy and support. Please see below for examples of services we have provided to clients. We are also available for custom educational programs that fit the needs of your small business, academic institution, hospital or clinic.

Regulatory Strategy and Support

• Serve as sponsor's and applicant's authorized representative to FDA
• Assist with and submit IND and IDE applications to FDA
• Assist with and submit 510(k) applications to the FDA
• Schedule, coordinate, prepare, and attend meetings with FDA
• Provide assistance to sponsors, investigators and sponsor-investigators during FDA inspections of clinical trials
• Develop regulatory strategy for product development, clinical trials, and product marketing
• Assessment of applicable IND/IDE regulations and regulatory obligations of client (sponsors, investigators, and sponsor-investigators)
• Assessment/determination of predicate devices and product classification
• Assessment of the content and format of IND/IDE applications
• Provide template documents for clinical monitoring, adverse event reporting, protocol development, annual reports, product disposition
• Interact with IRBs regarding research protocols and SR and NSR determinations
• Continue to monitor client regulatory obligations to ensure ongoing compliance with applicable regulations and reporting requirements
• Complete registration and send reminders of ongoing reporting requirements for ClinicalTrials.gov
• Provide assistance with e-submissions through FDAs Electronic Submission Gateway

Education

• IND and IDE application regulations, content, format, and processes
• Regulatory obligations of sponsors, investigators, and sponsor-investigators, from research concept to monitoring
• Assessment of predicate devices and product classification
• Assess the applicable IND/IDE regulations and regulatory obligations of sponsors, investigators, and sponsor-investigators for the lawful conduct of clinical trials
• Using templates for clinical monitoring, adverse event reporting, protocol development, annual reports, product disposition
• Role of the IRB regarding research protocols, SR and NSR determinations
• Establishing and managing project teams to provide applicable expertise
• Staff training for FDA inspections of sponsor, investigator and sponsor-investigator clinical trials
• The requirements of ClinicalTrials.gov and how investigators, sponsors and sponsor-investigators stay in compliance
• Customized newsletters with up-to-date information relevant to a specific client interest or need