REGULATORY PRESCREENING
SafeMark Regulatory Prescreen supports a strategic plan to present qualified name candidates to the core project team during the creative or name development phase.
SafeMark Regulatory Prescreen is performed on a list of proposed proprietary (brand) names and includes a similarity review, misbranding review and SRC Stem check.
Prior to July 2021, SafeMark performed a review of each name candidate for obvious sound-alike and look-alike conflicts in the US, EU and/or Health Canada region(s). In addition, a promotional review was conducted that identifies any obvious potential promotional concerns with regards to messaging such as overly fanciful claims and inappropriate medical terms and abbreviations. Finally, for added fees, ‘PLUS SERVICES’ were offered that included a review based on percent derivation, SRC STEM CHECK and a specific POCA search.
As of August 2021, SafeMark Regulatory Consulting ("SafeMark") provides a Prescreen Service to our partners that includes ONE SERVICE OFFERING - no longer STANDARD vs. PLUS services - for the same rate. We have also added a new "SRC" safety testing tool called SRC Prescreen Formula.
SafeMark's Prescreen Service includes the following 3-step process:
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Select Databases (i.e., US/FDA, Europe/EMA)
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SRC Prescreen Formula - is used to evaluate and help prioritize name candidates based on POCA and Word Construction Analysis. Names will either PASS or FAIL the SRC Prescreen Formula. A name that “FAILS” is excluded from further analysis. A name that “PASSES” will continue to the human factor similarity and misbranding review and SRC Stem Check. A client team specific POCA threshold may be included in this step.
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SRC Human Factor Analysis - Names that PASS the Prescreen Formula will be further analyzed based on SRC Stem Check, Percent Derivation (if active ingredient is provided) and a Misbranding/Potential Claims Review. In addition, the output may include suggestions to MODIFY the names based on the Human Factor Analysis results.
