Description

MONOCLONAL ANITIBODY (Pembrozulimab).

The final group project will be to create a regulatory strategy document. One of the major Regulatory Affairs contributions to the overall drug development effort is the regulatory strategy document. This document is commonly used in the regulatory field to provide a clear and concise understanding of the product’s development. Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical to the product’s market success.

PLEASE SEE ATTACHED DOCUMENT FOR MORE DETAILS. WE ARE DOING 1.3.3, 1.3.3.1, 1.3.3.2, 2, 2.1, 2.2