RISK ASSESSMENT

Do you need a proposed proprietary name reviewed for a regulatory submission because you recently received a rejection on a brand name? 

 

If so, consider SafeMark's Risk Assessment - a service that is an alternative process  to "full name safety testing" that offers clients an opportunity to prioritize a shortlist of candidates when timing and budget are restricted.  Please see details below.

  • Number of Name Candidates:  1 - 10 name candidates  

  • Similarity & Misbranding Review:  A Risk Assessment includes both a similarity and misbranding or promotional review of the brand name.  In addition, the SafeMark's Name Safety Testing Tools (e.g., FDA POCA system, SRC Name Pair Analysis, SRC Stem Check, SRC Word Construction Analysis, etc.) used in Full Name Safety Testing are used in a Risk Assessment to evaluate proprietary names

  • Scope of Work:  US/FDA, Europe/European Medicines Agency (EMA) or United Kingdom / MHRA. 

  • Submission Report:  Yes.  A proprietary name submission document is prepared based on the Risk Assessment on a single name candidate.

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