Balancing the intended desirable effects and undesirable effects or risks of a drug is a complex process, since it involves the evaluation of a large amount of data. Only drugs whose benefits outweigh the risks can be recommended for marketing authorization.
How can DDR help?
- DDR offers risk assessment from the analysis of non-clinical and pre-submission clinical data generated throughout the whole development process.
- DDR will help identify and minimize risks associated with the use of the product in patients, and facilitate the regulatory approval.
- Our team will evaluate your data with a specific focus on safety and the identification of adverse events and reactions, within the applicable regulatory framework. Should we make observations that have regulatory consequences, DDR will help you make the right decisions, which could lead to important changes in your drug development (e.g. changing doses, populations, monitoring activities and consent forms) to mitigate these consequences.