Regulatory Strategies

We support the entire registration process of new active substances and biologicals, re-registrations of active substances, biologicals and products, including zonal and national submissions.

Key elements are:

Data gap analysis
Development of regulatory concepts
Support during pre-application meetings with regulatory authorities
Selection of CROs for studies required
Study monitoring
Lower-and higher-tier risk assessment
Tailored statistical assessments
Literature searches and evaluation
Preparation of Dossiers
Submission (incl. IUCLID, dRR format or specific national formats)
Post-submission reports
Writing position papers, statements and scientific (peer reviewed) publications
Benchmark-dose and body burden modelling
Spatial analysis and modelling
Planning and realisation of events for regulatory topics

Our ecotoxicological in-house expertise is supplemented and completed with a network of cooperation partners