A UK based pharmaceutical company was engaged in filing detailed information on the active pharmaceutical ingredients (API) to the agency for the cross reference to Marketing Authorization Application (MAA). The primary target was to file an ASMF in eCTD format through gateways and the challenge was to go through various national submission procedures such as, CP, DCP, MRP, and NP.

Read more on how Freyr assisted the organization reaching out to the Europe region with streamlined ASMF submissions within 2 weeks.