We implement requirements and recommendations given in Commission Regulations (EU) No. 283/2013 and No. 284/2013, which set out the data requirements for active substances and for plant protection products, respectively, in accordance with Regulation (EC) No. 1107/2009.
Our expert team supervises all standard laboratory and tailored higher tier tests required for the registration of your active ingredient or plant protection product, including:
- Physical-chemical data
- Analytical methods
- Toxicological studies
- Metabolism and residue trials
- Testing of the fate and behaviour in the environment
- Ecotoxicological studies
We ensure that your studies are performed according to the relevant and latest OECD Test Guidelines, SANCO Guidance Documents or CIPAC methods, amongst others. Tests and analyses are commonly conducted in compliance with Good Laboratory Practice (GLP).
Challenge our experience in:
- Preparing appropriate and detailed working plans considering timelines, budgets as well as scientific and regulatory constraints
- Requesting quotes for your data gaps at the best-suited contract laboratories
- Organizing synthesis of radiolabelled test items and/or custom synthesis of metabolites
- Reviewing and implementing study plans according to scientific and regulatory guidelines and requirements
- Developing the most appropriate study design for difficult substances to fulfil compliance with guideline and regulatory requirements
- Discussing with the authorities the design of non-standard studies
- Following up for timely performance of studies
- Reviewing reports to ensure adequate and proper reporting
We monitor studies as a stand-alone project or as part of our full-service offer in combination with dossier preparation and submission.