Risk Assessment: Traditional and Novel Approaches to Assess and Manage Risks

Risk assessment is a complex process intended to protect human health by identifying drug-related hazards, determining dose-response relations for a product within relevant biological systems, and assessing exposure levels to characterize potential risks. These assessments may be conducted via traditional frameworks using data from in vitro and in vivo studies, as well as novel frameworks using pharmacokinetic and pharmacodynamic model-based […]

A Snapshot of Gap Analysis

When building a successful regulatory strategy, it is critical to keep the end objectives in mind and design a process that is tailored to your specific product. Planning for regulatory requirements can help you avoid non-compliant practices from the very beginning, but how do you make sure your strategy is comprehensive? The answer may be […]

3 Tips for IMPD Success

The Investigational Medicinal Product Dossier or IMPD contains summaries of information related to the quality, manufacture, and control of any IMP, along with data from non-clinical and clinical studies, including the overall benefit and risk assessment.   The IMPD is a critical part of the European clinical trial application, as the clinical trial may not be […]

The Essential Role of the CMC Expert

Recently, our colleague Marcus Delatte offered his insights about how a nonclinical expert1 can support the product development process and further advise sponsors on their applications for drug and marketing authorization approvals. The role of the Chemistry, Manufacturing, and Controls (CMC) expert is no less important. CMC applies to the entire drug product development lifecycle, beginning […]