What should be included in a regulatory submission that demonstrates adherence to applicable regulations and standards?

Including technical specifications of the product in a regulatory submission is essential because it provides a detailed description of the product's characteristics, formulation, manufacturing process, and intended use. This technical information helps regulatory agencies assess whether the product meets the required standards for safety, efficacy, and quality. By providing this information, the submission demonstrates compliance with applicable regulations and guidelines governing the development and approval of drugs.

Technical specifications are crucial for evaluating product consistency, understanding how the product works or interacts with biological systems, and ensuring that it can be manufactured reliably. This information also supports the claims made in the submission and is necessary for review by regulatory bodies.

While other aspects like the summary of internal quality assurance procedures, documentation of previous submissions, and a post-market surveillance plan can be relevant, they do not specifically address the technical aspects needed to evaluate the product itself. Instead, they may contribute to the overall understanding of the developer's adherence to quality standards or past performance but do not serve the core purpose of demonstrating product adherence to regulatory standards in the way that technical specifications do.