Regulatory Expertise

Over the years, FDA and EMA approvals have become the benchmark for successful global pharmaceutical brand development.

Although we know the evaluation criteria and methods the regulatory authorities use, there is a well-established, industry-wide dilemma: no matter how comprehensive the approach to address their considerations, their decisions can be perceived as arbitrary. The FDA and the EMA reject more than one out of every three marks submitted. This unpredictability makes regulatory approval the most demanding milestone in global pharmaceutical naming.

While we cannot eliminate the risk of rejection, can we minimize it?

At ixxéo, we can do much to minimize this kind of risk. To assure a favorable outlook for names submitted to the FDA, the EMA, Health Canada or MHLW, we leverage these primary points of difference.

A proactive approach We are the first naming agency to reduce the risk of overall project failure by using a 'prevention vs. treatment' approach. We incorporate key regulatory metrics as risk modifying agents, early in our Name Engineering process. The resulting benefit is an increased number of names with promising regulatory viability.

Superior implementation Our senior regulatory expert meticulously orchestrates the implementation of high-quality studies — pertinent and precise name safety research, Failure Mode and Effect Analysis (FMEA), and expert panels. These make the difference between well-founded insight and inconclusive data.

Compelling Submission Report The quintessence of our name safety research, expert panels, and regulatory reviews is compiled in a thorough and actionable synthesis of key findings and insights. This document supports our clients' regulatory submissions to the FDA, the EMA, Health Canada and MHLW, and contributes to obtaining name approval by these agencies.