We keep ourselves constantly up to date regarding all the EU regulations involved in the manufacturing, registration and commercialisations of FDF, APIs and intermediates in Europe, such as REACH, CLP, national and international directives.
Our Japanese offices provide regulatory support and this allow us to apply on behalf of our partners for Accreditation of Foreign Manufacturer (FMA), registration of Japanese Drug Master File (JDMF) and GMP Conformity Assessment, required for the sales of both APIs and FDF to Japan.
Full support is also assured to our partners who intend to sell APIs and FDF to China. Indeed, our Beijin office (SPC) provides the full regulatory support for obtaining the needed import licence.