When a company develops a product that represents uncharted territory for a regulatory agency, a standard approach does not always work.
The challenge was to get an antibacterial suture approved by the European Union, which had never reviewed such a product before. The suture was covered with an antibacterial coating, which the EU regulates as a drug. That meant the suture would have to be reviewed as a combination product. The process was hindered because European authorities had much less experience reviewing combination products than the FDA.
Because the EU had already approved the anti-microbial drug many years before, the client assumed that a complete drug review wasn't necessary. However, the EU drug authority decided that the standard approach didn’t work, and a full drug review was indeed necessary including additional data on the drug, specific to potential impurities - which were new to the client’s knowledge of the drug.
While the client, a major drug and medical device manufacturer, had significant internal analytical capabilities to assess drug impurities, the impurities in question posed a challenge in terms of time, resources and experience. The client determined it would take it up to 12 months to generate the data needed, an unacceptable timeline. Reaching out to the brand supplier of the API used in the suture, the client was referred to Quantum Analytics Group who had supported the API manufacture with impurities identification and analytical methods development.
Working with the client’s regulatory group, Quantum worked on evaluating impurities that would form on the sutures, developed and validated analytical methods to analyze for them, and produced the needed data.
By engaging Quantum, the 12 month timeline was reduced to just 60 days and the company was able to submit the additional requested data to the EU drug authority for final approval of the product – saving the client millions of dollars in time, resources and lost sales.