Regulis rescues failing EU market application

Regulis applies EU Regulatory Affairs expertise to rescue failing market application and delivers €3M revenue in first year sales.

Situation

A pharmaceutical company had submitted a marketing application for a new product seeking approval in ten EU countries. The company required a partner with specialist EU Regulatory Affairs knowledge to avoid a costly failed application.

Challenge

The regulatory assessment had been ongoing for almost a year and the authority had informed the company that they should withdraw their application in all ten countries because there were a number of shortcomings in their data and in their responses to questions. The authority recommended that the company start the whole process again; this would have resulted in a delay of at least 12-15 months in getting the product to market.

Solution

  • Using our significant knowledge of EU regulatory affairs and experience of interacting with regulatory authorities, Regulis was able to negotiate and secure one final opportunity to submit satisfactory responses to the agency.
  • Regulis built a constructive working relationship with the assessment team at the regulatory agency.
  • With our regulatory knowledge and scientific expertise to the fore, Regulis correctly interpreted the scientific product data and helped the company construct robust responses to the questions.
  • Regulis worked to the required deadlines to ensure the application succeeded.

Benefits

Our team’s deep and insightful EU regulatory affairs knowledge helped to deliver:

  • Licence approval in ten EU countries on schedule and avoided a 12-15 month delay.
  • Product sales worth €3M in Year 1.
  • A good reputation for the company in the eyes of the EU regulatory authorities.

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