Medical Device and Licensing Requirements for US Expansion

Closed
mid east canadian pharmaceutical inc
Markham, Ontario, Canada
kamiar tehrani
Employer
(12)
4
Project
Academic experience
120 hours of work total
Student
Anywhere
Advanced level

Project scope

Categories
International development Public health
Skills
medical devices research
Details

The goal of this project is to research medical devices and licensing requirements for our US expansion, create a comprehensive list of documents needed, and if possible, complete the application to apply for a drug establishment license and a wholesaler and distributor to sell products nation wide with registration in as few states as possible.


Deliverables

By the end of the project, students should demonstrate:


- Understanding of the medical device and licensing requirements for US expansion.


- Creation of a comprehensive list of documents needed to apply for a drug establishment license and a wholesaler and distributor license.


- If possible, completion of the application to apply for the licenses.



Final deliverables should include:


- A comprehensive list of documents needed to apply for the licenses.


- If possible, the completed application to apply for the licenses.


- A written report explaining the research and findings.


Mentorship

Weekly meetings with the students and the management team

access to existing research and data on regulatory affairs

access to company information

About the company

Company
Markham, Ontario, Canada
11 - 50 employees
Hospital, health, wellness & medical

Medical device and pharmaceutical company since 2017, our business is primarily B2B