RRAA

Our Regulatory Affairs team provides full regulatory and technical support to our customers.We can assist in marketing authorization applications, closely collaborating with our customers’ technical departments to lead their registration applications to success anywhere in the world.

We have great experience in registration either in USA/FDA (INDs, NDAs, ANDAs), Europe/EDQM (NPs, DCPs, MRPs & EMA/CPs) and Japan, as well as in many other Health Authorities in emerging markets (i.e: Brazil, Russia, China...), having submitted numerous DMFs/e-CTDs worldwide and holding several certificates of suitability (CEP/COS) for our products from EDQM.