For you research assignment, I want you to build a regulatory strategy timeline (commencing registration activities Q2 2021) in a PowerPoint presentation for a product of your choice, comparing the US with any other ROW country this class is covering (EU, Japan, BRICs, Canada etc) and an excel sheet of the documentation requirements (outline the most important ones) for the registration submission for that ROW country. Your commercial team is eager to launch as soon as possible, and in the presentation, you need to show to your team how you are looking for ways to reduce that timeline, while staying compliant to the regulations. Your commercial and logistics team also need advice regarding product distribution. Should they just find a distributor in that country, or open a subsidiary, and what are the regulatory risks to be considered during the assignment of the registration holder, any cultural differences we need to take in consideration before making these decisions?
Remember:
● The presentation should be 5-10 slides excluding cover and reference pages
● Remember the excel sheet as well!
https://www.discoverinternational.com/job/grl-188510
https://www.pharmaceuticalonline.com/doc/emerging-markets-and-your-global-regulatory-strategy-0001
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