Services

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. In addition, Arbit Consulting LLC also offers market research, strategic planning, product development, and communications.

Regulatory Strategy and Support

    • Serve as sponsor's and applicant's authorized representative to the FDA
    • Assist with and submit IND and IDE applications, including expanded access submissions, to the FDA
    • Assist with and submit 510(k) applications to the FDA
    • Schedule, coordinate, prepare, and attend meetings with FDAEstablishing and managing project teams to provide applicable expertise
    • Assistance during FDA inspections and post-inspection actions
    • Perform audits and prepare clients for FDA inspections
    • Products supported include drugs (Rx and OTC), devices, botanical drugs, cosmetics, nutritional supplements, combination products, GRAS substances and food additives

    • Assessment of applicable IND/IDE regulations and regulatory obligations of client (sponsors, investigators, and sponsor-investigators)
    • 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
    • Assistance during FDA inspections of investigator and sponsor-investigator clinical trials and post-inspection actions
    • Perform clinical trial audits and prepare clients for FDA inspections

    • Interact with IRBs regarding research protocols, applicability of FDA regulations, including SR/NSR determinations and risk assessments
    • Continue to monitor client regulatory obligations to ensure ongoing compliance with applicable regulations and reporting requirements such as annual reports, safety reports, and amendments
    • Complete registration and send reminders of ongoing reporting requirements for ClinicalTrials.gov

Custom educational programs that fit the needs of small businesses, academic institutions, hospitals and clinics.

Educational Services

Custom educational programs that fit your needs.

    • 510(k) application regulations and submissions
    • IND and IDE application regulations, content, format, and processes
    • Assessment of predicate devices and product classification
    • Determining IND/IDE applicability
    • SR and NSR risk determinations
    • GRAS Assessment

    • Regulatory obligations of sponsors, investigators, and sponsor-investigators, from study concept to monitoring
    • Protocol development
    • Clinical trial monitoring
    • Adverse event reporting
    • Annual report requirements
    • Pharmacy manuals and product disposition
    • Role of the IRB in clinical research
    • FDA inspections of investigators and sponsor-investigator clinical trials
    • Responding to FDA post-inspection actions
    • Requirements of ClinicalTrials.gov and how investigators, sponsors and sponsor-investigators stay in compliance

Presentations, workshop and training for:

  • Clinical researchers 

  • Sponsor-investigators

  • Industry sponsors

  • Medical device companies

  • Pharmaceutical companies

  • Research staff 

  • Clinical trial monitors

  • IRB staff

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Available for Speaking Engagements