At Anadiag we follow REACH regulation (Registration, Evaluation, Authorization and restriction of Chemicals) (CE) n°1907/2006 and CLP (CE) n°1272/2008 regulation for the registration of your physical and chemical substances.
Defitraces, one of our subsidiaries is doing studies under REACH regulation.
To know more : firstname.lastname@example.org
Defitraces – 150, rue Pré-Magne
69126 BRINDAS – FRANCE
We carry-out complete pre-evaluation dossiers. Our services include :
- The examination of all existing & available GLP and GEP studies, as well as a review of all reports provided by public bodies (universities, research centers, etc).
- Internal studies (non-GLP and non-GEP) to determine which non-official data can support the dossier.
- The active substance renewal dossier observation, to determine whether EU data is protected or not; and consequently, whether it can be used or not to build the dossier.
- The anticipation of all problems that could affect the dossier (toxicity, specific problems, analysis of reports…).
- Discussions about the best strategy for submitting the dossiers, in accordance with target country and chosen zones.
- Preparation of a business plan, in accordance with Regulation EC n°1107/2009 – this business plan will also indicate the global budget for the complete registration dossier, for one formulation.
Anadiag Group provides Biological Assessment Dossiers (BAD) and dRR Section 3 summary preparation. We offer an approach the complies with EU regulation 1107/2009 and relevant national guidelines.
Before the BAD preparation
For each use, we optimize your data packages use and anticipates authorities’ requests through :
- Definition of a bridging, extrapolation or analysis approach
- Data GAP analysis
- Monitoring of new trials, if required
During the BAD preparation
- A detailed evaluation of the key agronomic parameters of each supported use, combined with advanced product understanding knowledge, is required in order to draft realistic assessments and conclusions.
- We use a 2 steps approach to bridging justification, coformulation, and all analysis needed in the dossier.
- We carry out a complete and detailed resistance risk analysis. This analysis is based on depth knowledge of active substance(s), pest(s) and crop(s), supported by bibliographic search and data
After the BAD preparation
Anadiag offers support in relation to efficacy trial issues upon BAD preparation.