Regulatory Efficacy Services
Compilation of registration reports for agricultural inputs
Eurofins Agroscience Services provides a full range of services leading to the compilation of draft registration reports (dRR) for agrochemicals and biopesticides. The submission of efficacy and crop safety data to support an application for approval of any product is a requirement for member states in Europe and many other parts of the world. The data should be summarized to complete the objective of supporting all label claims corresponding with the GAP and recommended use pattern.
At EAS Group we have over 20 years’ experience regarding regulatory requirements for efficacy and crop safety, including preparation of all necessary documents for submission.
We have a large team of experienced personnel based across Europe in France, Germany, the UK, Romania, Spain, Poland and Belgium totally dedicated to dealing with these requirements and preparing dossiers for zonal and national submissions.
This team is further supported by members of our field network who have established contacts in national regulatory authorities in other EU countries.
The size and capability of our team enables us to prepare high quality dossiers in time to meet your submission deadlines.
We have broad-based experience of preparing dossiers to support applications for first approvals or re-registrations across all types of conventional and natural plant protection products, including herbicides, fungicides, insecticide, plant growth regulators, post-harvest treatments.
Within this team, there are dedicated experts to focus on bio-stimulants and special fertilizers (not EC), proposing audits for access to the market across all European countries. This includes compilation of the registration dossiers, declaration forms or local formalities as required, Mutual Recognition dossiers or advising on strategy and piloting projects for these special products.
One-stop service, world-class, worldwide
Full project management, where EAS Group provides management of a whole project to support the approval or re-registration of an active substance and/or products, is integrated into the structure of our organisation. The Regulatory Efficacy team work very closely with all colleagues involved in the project, including study and trials managers and team of experts covering all other areas of registration, to ensure an effective and successful outcome for the client.
In summary, our services include :
- Advising on study programs to fulfil the efficacy requirements for approval of PPP’s or specialty products (bio-stimulants, fertilizers) in the relevant countries.
- This analysis includes the need for studies in efficacy, crop safety and other aspects of efficacy including those for demonstrating the resistance risk, effects on quality and processing, impact on succeeding and adjacent crops, compatibility with current practices or alternative agricultural measures
- Performing data gap analysis on existing data packages (for all types of agricultural inputs)
- Compiling biological assessment dossiers, National Addenda and Section 3 dRR Part B summaries to support EU zonal submissions
- Performing audits and compiling registration dossiers or notifications for national registration of bio-stimulants/fertilizers
- Preparing national comparative assessments for products containing candidates for substitution
- Preparation of documents and cases to support applications for mutual recognition between countries
- Dealing with the national regulators on technical issues and submissions on behalf of the client
- Managing projects on behalf our client for improved efficiency
For further information, please contact us