Pharmaceutical affairs Department
After enforcement of the current pharmaceutical regulations in 2005, when foreign API manufactures register DMFs in Japan, foreign API manufacturers have to appoint DMFs in-country caretakers for APIs, for which foreign API manufacturers would like to register those DMFs. We register DMFs every year after the enforcement.
Our staff, who have expertise in analyses and syntheses for APIs, register DMFs on behalf of foreign API manufacturers.
In this year, the numbers of DMFs registered by our company is as follows:
year
DMFs registered by our company
2020
2+2(projected)
In order for foreign API manufactures to export any APIs to Japan, they need to obtain FMAs.
We also support foreign API manufactures to obtain FMAs.
We can address regulatory affairs, based on ICH Q7, ICH Q11, etc.
We support foreign API manufacturers to deal with regulatory affairs.
