Dossier Building and Reporting
We are experts at distilling the detail required from study reports and relevant publications and preparing fit-for-purpose robust study summaries.
Our Approach
Submission of dossiers of information to regulatory agencies has always been a critical aspect of regulatory sciences. What is stated in the dossier is critical to a product’s continuation of supply and use. It is the culmination of much of the work that we do. We view the quality and timeliness of this activity as our highest priority.
We have many years’ experience of putting diverse dossiers together capturing all the information that is available both through proprietary and public domain information.
Increasingly IUCLID is being used by regulatory agencies worldwide as the means for data submission. We have been involved with IUCLID since its inception in the 1990s (see IUCLID and Chesar).
Matched with our scientific skills this allows us to produce high quality documentation in the formats required by the regulatory agencies in a timely manner.
Quality robust study summaries are essential to preparing coherent and logical dossier summaries acceptable for regulatory scrutiny and these are written by our specialist staff.
With our unique IUCLID viewing and dossier comparison tool, study summaries can be reviewed and commented on in the dossier leading to automatic change management. A powerful way for multiple interested parties to review the same studies in the same dossier and in real-time.
Managing Your Dossiers
It is often a difficult task to keep up to date with all the changes needed in a range of dossiers, so they are kept up to date and compliant. The number of changes required by some regulators as their positions change, and changes to the IUCLID software, can be daunting.
We can help with this change management process with our software solutions integrating the management of the changes with the IUCLID software itself.
If information needs to be distributed to other parties our unique stewardship tool, Active Steward™, can be used to communicate with them and allow them to comment on files and download them when required. All dossier material can be delivered via a dedicated secure portal where you can:
- Download your updated IUCLID and Chesar files, CSR and associated validation reports before submitting your dossier
- Review versions of your dossier and comment on the changes made, suggest edits etc.
- All supporting information, read-across justifications, substance or category information etc can be reviewed via Active Steward™ along with multiple members of your team to comment and reply.
Contact us today
Expert management of your dossiers