What are the chief components of a regulatory submission?

The chief components of a regulatory submission are crucial for demonstrating the safety, efficacy, and quality of a product, particularly in the pharmaceutical and biotechnology sectors. The correct choice focuses on clinical, non-clinical, and manufacturing information, which encompasses the essential data needed for regulatory review.

Clinical information includes the results of clinical trials, detailing how the product performs in human subjects and establishing its safety and efficacy for intended uses. Non-clinical information refers to studies conducted in laboratories or through animal models, providing insights into pharmacology, toxicology, and other important bioassay results that support the product's development. Manufacturing information is essential as it describes the processes, quality control measures, and production capabilities ensuring that the product can be consistently produced to meet specified standards.

This integrated approach of clinical, non-clinical, and manufacturing information ensures that regulatory authorities can make informed decisions regarding the approval and monitoring of the product in the market. The other options do not encompass this comprehensive view, focusing instead on components that are either irrelevant or not sufficiently detailed for a regulatory submission.