Center for Regulatory Guidance

87 percent of the names we recommend are approved by global regulatory bodies. Just for perspective, the industry average approval rating for these regulatory bodies is about 62 percent. You do the math.

With our nearly 30 years of experience we leverage deep industry expertise to provide our global biopharmaceutical clients with strategic regulatory solutions and best practices when developing non-proprietary and brand names or conducting name safety research.

Our methodology for proprietary name development and testing is compliant with regulatory guidelines established by FDA, EMA/NRG, Health Canada, Japan’s PMDA, and support other global markets like Brazil, Russia, India, China and Korea. Our process for developing non-proprietary names is governed by the principles articulated by the USAN Council and WHO INN Secretariat.

Our established relationships with active regulators across the globe allow us to stay ahead of changes or updates that may be published. Our team is at the forefront of revised guidance before it is even published.

Dedicated to navigating the complicated pharmaceutical regulatory landscape, with you.

  • Regulatory name submission strategy and documents
  • Name safety research / gap analysis
  • Canada name safety research and failure mode and effects analysis (FMEA)
  • Consults and rebuttals
  • USAN/INN/stem & class naming
  • Nonproprietary (USAN/INN) name evaluations research
  • Non-proprietary applications / submissions
  • Product labeling, packaging & trade dress research
  • Regulatory / safety review of container, carton, labels & packaging

Unmatched expertise. Being a part of the Syneos Health Global Regulatory and Commercial Consulting Network allows our team to support any type of regulatory challenge. Unlike any of our competitors, our extended team of 100 regulatory professionals spans the globe with locations across North America, Western Europe, Eastern Europe, Latin America and Asia Pacific and has the ability to fully understand your challenges and the market in which your product will live post-approval.

Our regulatory specialists are scientists by training and experts in the area of regulatory intelligence and strategy. They have deep knowledge in CMC, biologics, biosimilars and small molecules.  Many have been involved in the actual development of regulatory guidelines, and have experience in submissions including INDs/CTAs, NDAs/BLAs/MAAs and ANDAs. By working with Addison Whitney, you can add unmatched value because of these resources within the larger Syneos Health organization.