Our services
Regulatory
Regulation in agrosciences is key for plant product registration. In compliance with European Regulations, we carry out personalized services for many products from pre-evaluation dossier to final submission.
Plant Protection Product & Biopesticides
We prepare dossiers for your active substance formulation, whether they are brand new or to be renewed, following the EU Regulation EC n°1107/2009.
Adjuvants
At Anadiag, we build your Dossier in compliance with the authorities’ requirements for adjuvant registration by following the national regulations under EC n°1107/2009.
Fertilizers & Plant Nutrients
Our regulatory team has 20 years’ experience in preparing dossiers for fertilizer and plant nutrient registration, in compliance with regulation (EU) N°528/2012 and the EU fertilizing products regulation (FPR) (EU) n°2019/1009.
Biocides
We conduct biocide studies, for all biocide product registrations (PT1 to PT23) : product protection, general biocides, pesticides, disinfectants etc.
Bio-compound agents/Biostimulants
We have many years of experience in testing and controlling biocompound agents. Our team is trained to manage your registration projects, from classifying your product to preparing the final report.
Reach
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 : info@defitraces.com
Defitraces – 150, rue Pré-Magne
69126 BRINDAS – FRANCE
Pre-evaluation dossier
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.
BAD Preparation
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.