Preparing Clinical and Non-clinical Datasets for Regulatory Submissions
Introduction
Regulatory submissions of clinical and non-clinical datasets play a vital role in the approval process of pharmaceutical products. These submissions provide Regulatory authorities with crucial evidence of the safety, efficacy, and quality of the products.
In this blog, we shall explore the importance of Regulatory submissions, the key considerations for preparing and submitting clinical and non-clinical datasets, and the role of data standards in ensuring compliance and supporting the approval process.