Navigating the regulatory landscape can be challenging if you’re not familiar with all the terms. Find a list of some of the key regulatory terms, processes, acronyms, and their definitions below.
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A document provided in manufacturing that reports on the quality assessment of the production lot.
A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate range to ensure the quality of the product.
A paper or digital document created and used in clinical trial research to collate standardized clinical data from each patient and transfer this data to Data Management.
The regulatory application format used internationally to seek new drug approval. This must contain all information relevant to demonstrate that the proposed clinical trial can be conducted safely as planned, and later on, that the drug will be safe for market.
The extensive electronic or paper document where the CTA (or IND in the USA) is organized, which is submissible within all regions and to all regulatory bodies.
A systematic method to determine the relationship between factors affecting a process and the output of that process. It is used to find cause-and-effect relationships through the design of experiments.
The specific requirements a company outlines for its warehouse, storage and shipping facilities, and departments.