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. 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
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