Responses to Authority Questions
- The preparation of written responses to questions received from regulatory authorities during the review of application dossiers can be decisive to the outcome of the dossier review.
- The questions posed by regulatory reviewers vary from straightforward technical queries to requests for new analyses or further interpretation of existing analyses.
- The challenge is not only to ensure that the responses contain relevant and focused content, but also to ensure that all team members are well prepared for responding to the questions before they arrive.
- Trilogy’s medical writers have made a substantial contribution to numerous client dossiers by ensuring that appropriate responses are prepared within the stipulated timelines.