Synageva, the biotech company I was working for, was submitting for the first time, for an enzyme replacement therapy dossier for a rare genetic disease. We had an expert regulatory team with excellent people. Nonetheless, Johan and Anne-Marie organized us in such a way that we were able to file faster than we had thought would be possible.
Johan and Anne-Marie were highly professional and competent. They integrated seamlessly with our internal team. They greatly enhanced our workflow and communications which allowed us to file a high quality, successful BLA and MAA ahead of schedule and much faster than industry norms. What’s more, they were a pleasure to work with.
Even if you have experience in-house, Anne-Marie and Johan can provide help, particularly with project management and all of the necessary functions that need to be put together to deliver a successful NDA/MAA/BLA. They have extensive experience and knowledge and are able to use their program management skills and interpersonal skills to help the internal teams function more effectively.
Mark Goldberg, former Executive Vice President for Medical and Regulatory affairs