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We provide job aids in PDF format in many different fields to keep you current and save you time. These PDF downloadable documents are available across many different fields, including: regulatory guidance, manufacturing and quality compliance regulations, approval process, and relevant Best Practices (GMP, GDP, GCP, GLP, GVP, GPP, GTP, …) in drugs, medical devices, combination products, food & food ingredients, dietary supplements, and complimentary & alternative medicine. They are available for a small fee or free of charge. Simply search by category then browse to find the document you need. New PDF documents are added on a daily basis so please check often.
Using this Expedited Adverse Event Reportability Assessment Chart, you will learn how to follow the thought process for decisions on whether an adverse event is subject to expedited reporting or not.
A series of graphic aids (11 Human Subject Regulations Decision Charts) for entities who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the US Department of Health and Human Services (HHS) regulations at 45CFR part 46.