The authorisation of a plant protection product is linked to the approval of active substances on the EU level according to Regulation No. (EC) 1107/2009. The approval procedure is a lengthy process that consists of several steps and involves authorities and official bodies on the member state and EU levels (RMS, EFSA, SCoPAFF, COM).
Generally, an (re-)approval is granted for 10 to 15 years and has to be renewed in time in order to stay on the market.
These are costly and time-consuming processes that are often not managed by one applicant alone, but rather by a group of applicants that share an interest in the active substance and the high costs.
We offer effective taskforce management: We help you to work efficiently with industry partners, authorities and contract research organisations (CRO) while guaranteeing the secrecy rights of all involved stakeholders.
We have extensive experience with active substance approval and renewal. We support you with our know-how and experience in solving specific problems and we can also manage the whole process for you
– you choose the model that meets your needs:
- Taskforce management (meeting & account management)
- Data gap analysis (initial completeness checks)
- Maximum residue level (MRL) applications
- Technical equivalence applications
- Literature research
- Preliminary or final risk assessments
- Study monitoring and management
- Dossier preparation
- Contact with the authorities
- Post-submission management
With our step-wise and modular approaches as well as close follow-up during the approval processes, we minimize your risk and optimize your resources.