I worked as an intern for a commercial technical operations team at a biopharmaceutical company, where some of the documentation I worked with was regulatory filings from different markets including the U.S., Europe, and Japan. There was some disconnect between the filings as some markets are stricter than others regarding certain aspects of the biologic, or require more documentation on manufacturing processes. This was also likely due to the staggered submission timelines. One of the ways I supported the team was review of the various biological filings with the ultimate goal of harmonization. 

I was wondering how other companies go about the process of filing with multiple international agencies? In your opinion, how should this process occur? Do you believe this should be a priority consideration when preparing to submit for approval to an agency?