A challenging regulated environment requiring a high level of expertise
The crop protection sector is heavily regulated - In Europe for instance the regulations (EC) No 1107/2009 and (EC) No 396/2005 have been designed to safeguard human health and the environment. Compilation of robust registration dossiers requires thorough knowledge of these regulations, their data requirements and technical guidance documents.
Since the implementation of these regulations, the complexity of the risk assessments for human health and the environment has drastically increased. This challenge for Eurofins Agroscience Regulatory (EAR)? To ensure a high level of expertise in regulatory affairs and higher tier risk assessments to best advise the crop protection industry, ensuring their innovative products can enter the key agrochemical markets in the most efficient way.
- Analysis of business objectives and proposition of cost / time efficient regulatory strategy for both actives and formulated products across key regions (Europe, LATAM, NAFTA and APAC)
- Full package end-to-end service for your registration dossier
- Performance of the data gap analysis, risk-assessments (from preliminary to higher-tier)
- GLP and GEP study monitoring
- Coordination, preparation and submission of your registration dossiers including Biological Assessment Dossiers (BADs)
- Discussions with competent authorities (from pre- to post-dossier submission)
- Life-cycle-management of the active and/or formulation
- Project management
Through our global Eurofins network we can also offer a full range of testing services required for your crop protection product.
Our promise to you:
Provide the highest quality service to address all your current and future regulatory challenges
For further information, please contact us