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ADC GmbH
Agricultural
Development
Consulting
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• Support clients planning, definition and decision processes
– Support selection of areas and crops to cover (for example
manage specific market studies)
– Ensure that at the time of planned submission, the dossier
is complete and sufficient to support Annex I listing
– ensure that all type of studies requested will be done at
the optimal timing during the process in order to minimize cost
– type and number of trials per crop and area required to
provide a convincing biodossier as to the defined standards of the registration
officials.
– pre-define milestones and decision points in the planning
process
– Registration strategy from the biological point of view:
Rapporteur member state for Annex I listing, feasibility of a co-rapporteur
approach, optimized timings of the country applications
• organize preliminary trials in a way, that under optimal
conditions they can be used in the core dossier
– optimize trial distribution across EU countries in a way to
make use of best offers (price differences across the countries) without
jeopardizing to meet the requirements of a specific country
– ensure that all type of trials requested will be done at the
optimal timing during the process (for example taint test ect. not in a phase,
where still changes in formulation or rate are possible due to results of
preliminary efficacy work)
–
Summarize
trials and write the biological dossier meeting the EU requirement for EU and
individual country submission
• Provide a budget plan including a predicted cash flow plan
in line with the agreed planning
– Follow budget vs. planning
– Prepare all required efficacy and selectivity protocols in
detail to ensure trial reports, that can be used across the target countries in
the dossier and in marketing
– Plan required field parts for residue analysis
– Contracting individual trials in line with the strategy.
Follow invoices and payments vs. the results available
– Checking trial quality and especially reporting for use in
biodossier
– Act as Study director for GLP residue studies
– Organize sample shipment to contractors
• Ensure proper data storage (electronically as well as on
paper for registration needs)
– Convert data reports from different sources to a common
format. (For example data entry into ARM)
– Summarize the data and make recommendations based on the
data vs. adoption of the planning
– Adjust label as soon as new knowledge has to be included
•
The solution
for creation of data summary tables from ARM data files:
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We provide
you with summary tables from your ARM data files in the format you want/need.
Tables as to EPPO, Canadian reporting format or country specific requirement
– All
information, including details on trial sites can be included in these tables
– Statistical
data analysis also across trial sites
– "Translation" services provided by
agronomists: We create ARM files from your paper reports (French, German or
English). For other languages - we will find the solution for you
·
For questions of data handling,
in agreement with our customer, we closely work together with Demeter data management
– Support all activities around the planning and organization
of the market introduction
– Organize User reliability trials
– Compile FAB (features advantages benefits) data package for
support of market introduction
– Summarize and statistically analyze data for product
introduction
– prepare presentations for marketing use