NAMs Readiness Assessment

Evaluate your organization's readiness to adopt New Approach Methodologies. Assess infrastructure, personnel, processes, regulatory preparedness, and culture.

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Infrastructure
Equipment, facilities, and technical capabilities
Do you have dedicated lab space for NAMs platforms?
Do you have NAMs equipment (OoC systems, imaging, etc.)?
What is your data management capability for NAMs?
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Personnel
Expertise, training, and staffing
Do you have staff with NAMs expertise?
What NAMs training programs are available?
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Processes
Protocols, SOPs, and workflows
Do you have validated NAMs protocols/SOPs?
How integrated are NAMs into your workflows?
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Regulatory
Compliance and submission readiness
Have you engaged FDA on NAMs strategies?
Do you have regulatory-grade documentation?
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Culture
Leadership support and organizational buy-in
What is leadership's commitment to NAMs?
Is there budget allocated for NAMs?
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