Sourcing Documentation

A comparator product was being sourced from the US, where Certificates of Analysis (COA) are not normally issued, to a client in Germany. The product was being re-exported to Latin America. Four months into the trials a site was opened in a country requiring COAs. This involved trying to obtain the document from a pharmaceutical company in the US, well known for withholding such information. The problem was compounded in that the client didn’t want the innovator to know of their clinical activities. BAP, through good contacts with the US wholesale network, was able to obtain the required documentation allowing the client to complete its clinical programme as planned.