Regulatory Research & Consulting

healthcare and pharmaceutical regulatory research and consulting

A compelling brand is what everyone wants, but the road to get there requires a level of expertise that very few possess. A sophisticated research methodology is the backbone of the Addison Whitney process.

By thoroughly testing and evaluating brand name candidates, we reduce the potential for medication error by uncovering phonographic and orthographic issues that may compromise patient safety. But research alone means nothing without expert analysis. Examination of data is the foundation by which our brand recommendations are made – ensuring the development of safe brands and increasing the likelihood of regulatory success.

Our research capabilities include:

  • Scientific Brand Physician Validation Research: Using market research strategies and practices to ensure drug name safety through name confusion evaluations.

  • POCA (Phonetic Orthographic Computer Analysis): FDA and Health Canada utilized analysis for name safety and name confusion for pharmaceutical brand names.

  • Name Validation Research (Regulatory & Marketing): Name safety name confusion market research, medication error prevention, prescription simulation, FMEA drug name testing.

  • Regulatory Name Submission Documents and Consulting: Creation and submission of FDA, EMA and Health Canada regulatory name submission reports, including IND/NDA brand name and trade name review.

  • Logo Validation Research (Regulatory & Marketing): Research to validate that a developed logo is in alignment with necessary regulatory and marketing/trademark standards.

  • Scientific Brand Validation Research: Marketing research to validate the specific branding elements on the market throughout the asset lifecycle and across therapeutic areas.

  • Brand Discovery/Positioning Research: Brand discovery positioning and research, brand perception identification. An essential step in the early stages of brand development. 

  • Brand Equity Tracking: Assessment to determine the sentiment of a brand’s target audience and how your brand fits within your specific market space.