REGULATORY PRESCREEN

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.

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SafeMark Regulatory Consulting ("SafeMark") provides a Regulatory Prescreen Service to our partners that includes ONE SERVICE OFFERING that can be used for groups of 50 to 100 names. We include our name safety testing tool called the SRC Prescreen Formula.  

SafeMark's Prescreen Service includes the following 3-step process:  

1. Select Databases are used for region specific searches including drugs@FDA (US), article 57 (EU), drug product database (Canada) to generate potential obvious conflicts.  

2. SRC Prescreen Formula - is used to evaluate and help prioritize name candidates based on FDA POCA System and Word Construction Analysis.  Names will 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 & misbranding review, percent derivation and SRC Stem Check.  

3. SRC Human Factor Analysis - Names that PASS the Prescreen Formula will be further analyzed by SafeMark and each name output includes a Yes, No or Maybe which include suggestions to MODIFY the names based on the Human Factor Analysis results. 

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