Regulatory Affairs Case Study – Moving to OTC
Every day we work with some of the world’s biggest and most dynamic healthcare companies in the pharmaceutical and medical device sectors. Our team has a well deserved reputation for service excellence and their ability to successfully manage the most complex issues on behalf of clients. That is why we have had a 100% success rate since 2002. In this regulatory affairs case study we look at an issue faced by a client and how we overcame that issue successfully.
Recently we helped a client overcome a series of significant regulatory roadblocks to achieve a successful product launch. The client needed to reclassify their ‘First in Class’ product to ‘Over The Counter’ status. We advised them of the data requirements and guided them through the submission process. Following approval of the reclassification, we were faced with the next challenge – to change the invented name of the product to support the clients’ marketing strategy.
The company had previously tried to get their chosen name approved without our help, however on that occasion they had been unsuccessful.
Our long standing positive relationship with the Competent Authority allowed us to arrange a meeting with the relevant assessors. We presented new perspectives and a strong rationale to overcome their objections. These were accepted by the Competent Authority and our client was granted their chosen product name, which was essential to their brand.
The client would not have been able to change the invented name or bring their reclassified product to market without our assistance. In seeking our assistance, they overcame significant hurdles that they had not previously been able to overcome.
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