Consultancy services and Regulatory Affairs – Study Monitoring and management
DEVREG services on development are focused on the management and monitoring of development programs in Europe, in collaboration with different CROs and laboratories, to provide a consistent data package for registration of agrochemicals in Europe.
DEVREG offers a complete service on field trials coordination assisting the Client Development Manager in trial planning and executes the set-up and documentation of trial protocols for any GEP field efficacy trials as well as for GLP-study plans.
DEVREG offers the assistance for contracting trials and follow-up with external CROs regarding trial progress, data capture and reporting. DEVREG also supports Client Development Manager as a second interface for any trial related activities towards Regulatory, Stewardship or Research groups.
Development coordination activities include:
- Trial planning under direction of the Client Development Manager.
- Trial supervision and reporting, summarizing and initial data interpretation.
- Work with regulatory group in the establishment of GEP and GLP-study plans for field trials and ensuring that all necessary data capture is reflected in the trial protocol.
- Assist Development Managers in coordinating efforts with Regulatory, Stewardship and Research groups.
- Review of service provider contracts for adherence to administrative and operational procedures.
- Assist with updating of planning records and trials status to Development Manager.
Coordination and monitoring activities are related the following regulatory areas:
- Physico-chemical and technical properties of plant protection products.
- Validation of methods of analysis.
- Efficacy and crop safety programmes, including processing studies, taint tests, etc.
- Acute toxicity and irritantion studies (in vivo and in vitro).
- Dermal absorption studies.
- Field exposure studies, DFR, etc.
- Residues on plant and plant products.
- Ecotoxicology studies