safemark regulatory consulting

The healthcare branding and pharmaceutical branding world is incredibly intricate. The discrepancy of a few letters in a name may not only mean the difference between regulatory approval or rejection, but could have life or death ramifications.

Our partner brand, SafeMark, is redefining the safety industry by implementing a new gold standard in name safety testing. This partnership enables us to provide our healthcare clients with a next-level simple and sequential approach to name safety testing that adheres to guidelines set forth by global regulatory authorities.

Be smart. Safety first. Go beyond.

The healthcare and pharmaceutical branding world is incredibly intricate. The discrepancy of a few letters in a name may not only mean the difference between regulatory approval or rejection, but could have life or death ramifications.

Our partner brand, SafeMark, is redefining the safety industry by implementing a new gold standard in name safety testing. This partnership enables us to provide our healthcare clients with a next-level simple and sequential approach to name safety testing that adheres to guidelines set forth by global regulatory authorities.

Be smart. Safety first. Go beyond.

OUR ANALYSIS LIVES IN A LEAGUE OF ITS OWN

REGULATORY PRESCREENING AND CONSULT

  • If you need a regulatory strategy or proposed response to a regulatory agency regarding a proprietary or nonproprietary name, we offer regulatory consulting services to help.
  • If you have one name or a set of names for regulatory submission, SafeMark can assist in prioritizing your naming options regardless of whether we helped with the original Name Safety Testing.
  • SafeMark can help to explore your naming options if you have a rejection from a regulatory agency.

SAFETY TESTING

SafeMark’s unmatched approach to safety testing follows three simple and sequential steps, resulting in a transparent, efficient, and comprehensive process.

  • Initial Brand Name Review (PreMark)
    Before launching straight into full safety testing we analyze and assess name candidates through PreMark. This step consists of a set of 27 unduplicated questions based on regional regulatory guidance documentation to assess word construction, sound-alike/look-alike conflicts, promotional claims, and elements of confusion. This data is used alongside an in-depth POCA evaluation to ensure that our clients have the upmost confidence in the list of name candidates prior to moving into full safety testing and simulation.
  • Prescription Simulation Study (RxSim)
    Many regional regulatory authorities – including the FDA, EMA, and Health Canada – address prescription simulation in their guidance. RxSim emulates real-life prescription orders through the collection and interpretation of handwritten, verbal, and electronic orders amongst validated healthcare professionals tailored to the product’s specific prescribing environment to test for likelihood of confusion.
  • Safety & Commercial Evaluation (ProMark)
    ProMark provides comprehensive safety testing and evaluation of likelihood of confusion and associated risk for those regions that do not require prescription simulation testing, including Japan, Latin America, South Korea, and others. ProMark is conducted amongst validated healthcare professionals for thorough evaluation that goes beyond industry standard and may be expanded to include patients for commercial evaluation.

Why settle for just a single study with limited questions when you can ask more, get better data, and make the best decisions. Ask us about our commercial metrics and BrandScore!

SUBMISSION REPORTS

  • If you need a regulatory submission report for a proprietary or nonproprietary name to be submitted to a regulatory agency, we can help draft either a cover letter or the submission document.

TRAINING AND EDUCATION SERVICES

  • SafeMark can customize a tailored education and/or training program for your team.

LEADERSHIP TEAM

CLAYTON TOLLEY

President & CEO

As President and CEO for Brandsymbol and CEO of SafeMark, Clayton’s collaborative philosophy fuels the growth for the agency and its teams.

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[8:49 AM] Jacob Lindgren
Brand Name Annual Review