RISK ASSESSMENT

SafeMark's Risk Assessment is a service offering that is an alternative to "full name safety testing" that offers clients an opportunity to prioritize a shortlist of candidates when timing and budget are restricted.  SafeMark's Risk Assessment evaluates proprietary names based on the same criteria the Agency's use and utilizes the same databases as well as the SRC Name Safety Tools (e.g. FDA POCA system, SRC Name Pair Analysis, SRC Stem Check, SRC Word Construction Analysis, etc.) used in Full Name Safety Testing.   Please see details below. 

  • Name Candidates:  Up to 10 name candidates  

  • Source of Name Candidates:  In most cases, a Risk Assessment is performed on a shortlist of name candidates from a global name bank, alternatives created based on an Agency rejection or from a past name safety testing project on another product.

  • Scope of Work:  United States/FDA, Europe/EMA, Brazil/ANVISA or Japan.  

  • Target Audience: Internal SafeMark reviewers participate in all Risk Assessments.  External Healthcare Professionals may be included, ranging from 5 to 12 respondents per region.

  • Submission Report:  Yes.  A regulatory submission document on a single name candidate for a specific Agency (e.g. FDA, EMA, Brazil) is offered based on the Risk Assessment.

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