Study management
We have the resources and experience to manage the process of commissioning new studies in compliance with KKDIK, including assistance for situations where the Ministry of Environment and Urbanization (MoEU) has assessed dossiers to be incomplete or inaccurate.
Particularly in the case of substances with a high hazard potential, certain studies should prove or disprove the assumed substance properties. Such a decision by the MoE has consequences for all companies who have registered the substance in the volume band for which the additional study is required and they need to share the costs.
In order to best manage the process of commissioning a new study and, above all, to coordinate the associated cooperation of all parties involved, we support you with the following activities:
- Evaluation and commenting of MoEU decisions and strategic planning
- Request and evaluation of laboratory offers
- Communication with MBDF / consortium members, co-registrants, authorities and laboratories
- Budget planning
- Calculating and invoicing cost shares of study fees
- Technical study monitoring by experts
- Archiving of study reports
- Updating the registration dossier with the newly obtained study results by experts
- Management of MBDFs and consortia
- Letter of Access management
- Study management
- Data management