Our Services

We have more than 30 years of experience in the regulatory affairs of agrochemicals and biopesticides. Our experts support you with a wide array of services.

• Data gap analysis
  Review of available data and conduct of preliminary risk assessments to check whether current regulatory and guideline requirements are fulfilled and to identify lack of data required according to latest precepts.
• Monitoring of studies
  EU study notification, identification of suitable contract labs and CROs, requesting and evaluating quotations, development or review of study plans and reports against guidelines and requirements and audit of study performance.
• Efficacy
  Study design and evaluation of efficacy trials, preparation of Biological Assessment Dossiers incl. comprehensive resistance risk analysis.
• Endocrine disruption (ED)
  In-depth assessment of toxicological studies (GLP and published literature), development of lines of evidence, discussion of possible modes of action, development of testing regime for assessing endocrine effects, monitoring and support during study conduct.
• Literature evaluation
  Screening of published literature for relevant data and reliability evaluation.
• Comparative assessment
  Support with the preparation of comparative assessments for products containing candidates for substitution (CfS).
• Dossier preparation
  Preparation and submission of summary dossiers (dRR and CA/CP-format) in IUCLID and CADDY. State of the art risk assessment applying the current and future (as far as available) calculation tools for active substance/lead formulation approval on EU-level and for national product registration. Preparation of science based expert statements.
• Zonal and national approaches
  Consultation on EU-wide and national approaches for zonal and national applications including mutual recognition and specifically registrations in Germany. Notification, application and follow-up of applications, assistance to achieve timely approvals, legal support by cooperation with specialised law-firms.
• Active substance renewal
  Full service for active substance renewal, identification of data gaps, development of strategies and approaches for problem solution, cost estimation of the entire application and management of taskforces and consortia.
• Support in legal disputes
  Close cooperation with specialised law firms as scientific advisor to ensure that your applications are processed by the regulatory authorities in a timely and legally compliant manner.

Our experienced team is dedicated to navigating the complex regulatory landscape, ensuring that your products meet all necessary requirements for successful market authorization