Resources
Stay up to date with the U.S. Food and Drug Administration (FDA) regulatory framework that governs the development, testing, manufacturing, and approval of drugs and biologics. This resource section provides links to key guidance documents, submission requirements, and quality standards to help ensure your research and development activities align with FDA expectations. With an increased focus on manufacturing compliance and data integrity, understanding FDA regulations is more important than ever for successful product advancement.
Navigate the Canadian regulatory landscape with official resources from Health Canada, the federal authority responsible for drug, biologic, and clinical trial oversight. This section includes guidance on preclinical and clinical submission pathways, Good Manufacturing Practices (GMP), and safety reporting requirements. Whether you're conducting early-stage research or preparing for market authorization, these materials support alignment with Canada’s evolving life sciences regulatory environment.
The Canadian Council on Animal Care (CCAC) sets the national standards for the ethical use and care of animals in science. This resource provides access to CCAC guidelines, policy statements, and certification frameworks to help institutions and researchers ensure that their in vivo studies meet rigorous ethical and welfare standards. Adherence to CCAC principles is essential for institutional approval, public trust, and compliance with funding and regulatory bodies in Canada.