Which phase of product development focuses primarily on collecting data for regulatory submission?

The clinical trial phase is focused primarily on collecting data that is essential for regulatory submission. During this phase, a product is tested in humans to gather vital information about its safety, efficacy, dosing, and overall performance. This clinical data serves as critical evidence for regulatory bodies to evaluate whether the product should be approved for market entry.

The trials are designed to answer specific questions about the product's effects and potential adverse reactions, which are necessary for informing regulatory agencies like the FDA or EMA. The outcome of these trials directly impacts the regulatory dossier, which is submitted to seek approval for marketing the product.

In contrast, the design and development phase involves conceptualizing and creating the product but does not focus specifically on data collection for regulatory purposes. The preclinical phase includes laboratory and animal studies aimed at assessing safety before testing in humans, while the market launch phase concentrates on post-approval activities, marketing strategies, and distribution rather than on data collection for regulatory submission.