Product Development Plans

The objective of the product development plan is to provide solutions to regulatory, scientific, and clinical challenges and act as a blueprint for registration and approval of the product.

The product development plan will assess the existing data, evaluate similar types of products, any regulatory precedents, and provide an overview of regulatory requirements for the product type.  This will form the basis to determine the requirements for clinical studies, considering any hazards and suggesting innovative solutions using the currently accepted scientific and regulatory framework.