The purpose of Establishment Licensing (for Drugs) and Site Licensing (for NHPs) is to ensure that manufacturers and other parties responsible throughout the continuum of distribution will comply with GMP. For medical devices, the goal of establishment licensing is to ensure compliance with the Medical Device Regulations.
GMPFor drug products, the following activities are subject to drug establishment licensing:
DSA works with clients from the very initial stages of the project to help determine what type of establishment or site license is required.
DSA can handle the entire scope of the project from license application through to preparation of Standard Operating Procedures, GMP/SOP training, and preparing the facility for a site inspection by Health Canada.
By acting as the firm’s Head of Quality Control, DSA can manage the entire process from application through to successful licensing.
Contact us to find out more about our regulatory consulting services or download a free copy of our DSA Whitepaper on marketing a health care product in Canada.