Anadiag Hellas provides services for the preparation of high-quality Biological Assessment Dossier.
Our appoach complies with regulaton (EC) 1107/2009 and national relevant guidelines.
We offer:
- Stong agronomic expertise
- Persuasive data presentation, including graphical representation
- Complete adherense to authorities' requirement
- Data GAP analysis
- Selection of trials to be included in the Dossier
- Strong agronomic and plant pathology expertise, to provide argumentation in support of the label claims, in the event of data are not entirely sufficient
- Mutual recognition approach within the “EPPO Climatic zones” and following the new regulatory areas
- Support for the pre-submission meeting
- Update of BADs and dRR concise summaries with new data
- Preparation of responses to authorities’ comments upon assessment
For more information contact us