Biologics Regulatory Document Library

Many regulatory guidelines must be followed for you to meet the specific requirements of the territory in which you intend to market your product. Experience with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Ministry of Health, Labor and Welfare (MHLW), and other regulatory agencies, allows Charles River’s technical and quality assurance personnel to have the regulatory knowledge you need to accelerate the development of your biologic.

We have compiled this online library of regulatory documents to assist you as you move through your development and release process. Select both the topic and agencies you want to view below to access the guidelines.