With its many years of experience, the AGREXIS team can support you effectively at all stages of registration of agrochemicals and biorationals within the EU.
Regulatory Fitness
- Data gap analysis
- Registrability / Re-registration assessments / Preliminary risk assessments
- Data protection and access
- Second opinion
- Pre-submission meetings
Regulatory Strategy & Management
- Task Force management
- Due diligence
- Data sharing
- Regulatory management
- Public & Government Affairs
Dossier
- Chemical active substance approval / renewal
- Biorationals
- Product registrations
- Pre-submission meetings
- MRL submissions
- Technical equivalence
- Data compilation and upload by IUCLID
Regulatory Science &
Product Safety
- Completeness and compliance of data set
- Preliminary risk assessments
- Complete coverage in risk assessments
- Study design and monitoring
- Modelling
- Literature search and review
- Peer reviews
Efficacy
- Registration support services
- Data gap analysis
- Trial planning and monitoring
- Data compilation
Project Management
- Project plan
- Project execution and communication
Task Force Management
- Chair and secretary of task forces
- Project execution and communication
- Covering regulatory/scientific as well as administrative aspects
- Financial administration
- Representation of clients in task forces