Regulatory Affairs

Regulatory affairs

Before a medical or pharmaceutical product can be placed on the national market, it must prove that it is safe, effective and of good quality. Only then will a national regulatory authority grant marketing authorization. We have extensive experience with leading pharmaceutical companies and manufacturers of medical devices in the approval process, both in Europe and with the national authorities in China.

The authorities take the final decision on whether to approve or reject the product on the national market. We build up a lively exchange of discussions with health authorities, e.g. in China, which increases the probability of rapid market approval, accelerates the process and creates transparency in the cost structure.