Developing an innovative healthcare product (a drug or a biologic, or a medical device) from the proof-of-concept stage to the marketing stage is an expensive and complex process. It involves many years of research and development work.

Download and use this guide to:

  • Recognize and implement all the steps for healthcare product development
  • Interact effectively with regulatory agencies
  • Follow best practices for documentation and regulatory submissions
  • Achieve product-related quality, safety and efficacy
  • Understand the regulatory submission process in Canada, the US and the EU
  • Comply with regulations that govern/prohibit the advertising and promotion of licensed/unlicensed products

Navigating the regulatory landscape for healthcare product development: Key principles and best practices

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This guide is not a compilation of regulations. Rather, it is a collection of articles that discuss the fundamental concepts and principles in regulatory affairs.

The articles compiled in this guide were originally published by MaRS in October 2012 in the Entrepreneur’s Toolkit. Written in plain language, the guide aims to facilitate the regulatory understanding that governs healthcare product development and ensure regulatory compliance in these activities. It is intended as a starting point to assist entrepreneurs in developing their product.

Disclaimer: The information presented in this guide is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of October 2012 and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development program. Specific advice should be sought from a qualified healthcare or other appropriate professional.