SafeMark provides services to branding agencies and the healthcare industry for the evaluation of proprietary (brand or trade names) and nonproprietary (generic or active ingredient) that are being considered for regulatory submission.   


Our services apply to drugs for human use, medical devices, biologics including biosimilars and vaccines, veterinary or animal health products and over-the-counter products including Rx-to-OTC switch products. 

We evaluate brand/nonproprietary names that are being considered for submission to the following agencies: 

  • United States/ Food & Drugs Administration

  • Europe / European Medicines Agency (EMA) - our standard methodology includes EU 11 (France, Germany,  Italy, Netherlands, Poland, Denmark, Greece, Spain, Sweden, Portugal, and United Kingdom)

  • European National Agencies 

  • United Kingdom / Medicines and Healthcare products Regulatory Agency (MHRA) 

  • Canada/ Health Canada (HC)

  • Brazil / ANVISA

  • Other Regions:  Japan, China, India, Australia, Latin America 

  • United States Adopted Name (USAN) Council

  • World Health Organization (WHO) International Nonproprietary Name (INN)​​​



Learn more about our global services.