WORK Sheet #2 1. Physical abuse/ recognition and interviewing 2.

Objective of this Assignment: To prepare a response to a Request for Proposal (RFP) from a foreign drug company who wants to file a New Drug Submission to license their new drug for commercial sale in Canada. Instructions: You will compose a response to a Request for Proposal (RFP) from a foreign drug company who wants to file a New Drug Submission to obtain authorization to sell a new drug in Canada. The company also wants to obtain some information on timelines and fees to market this new drug the US. Their new drug product is a novel biologic with a new active substance administered to subjects intravenously which is intended to be approved to treat a life-threatening disease known as “Fabry disease”. As a Regulatory Affairs Associate and using your Regulatory Subject Matter Expertise, you will respond to their inquiries by addressing the questions below and relying on the instructions provided in table 1 and table 2 on pages 2 and 3. 1. How long does the New Drug Submission (NDS) review process take and what is the typical process/steps? What kind of information do we need to supply in the NDS Modules? 2. How much does a NDS cost in Canada? Is there is an opportunity for submission fee reduction and if so, what are the eligibility requirements? 3. How much does a New Drug Application (NDA) cost in the US? Is there is any opportunity for submission fee reduction and if so, what are the eligibility requirements? 4. Is it possible to accelerate the approval time

******CLICK ORDER NOW BELOW AND OUR WRITERS WILL WRITE AN ANSWER TO THIS ASSIGNMENT OR ANY OTHER ASSIGNMENT, DISCUSSION, ESSAY, HOMEWORK OR QUESTION YOU MAY HAVE. OUR PAPERS ARE PLAGIARISM FREE*******."