Your company has a formulated product which you believe is of good quality and suitable for placing on the EU market. You might even have the product on the market outside of the EU already, and you are looking for advice on what needs to be done to place the product on the EU market and how high the financial investment would be.
If you are already present in the EU market and you are looking for ways to get to non-EU markets, we can also advise you here, or put you in touch with local experts who are able to offer additional guidance and support.
- Preliminary Assessment of your portfolio or individual products taking the EU status of your substance as well as data protection rules into consideration. We prepare a data gap analysis (DGA) by indicating what studies would need to be generated to comply with the data requirements of your substance/formulation and we estimate the cost of study generation for you
- Support with acquiring Equivalence Assessment of Active Substances by helping you prepare the documentation needed for Tier I and, if necessary, Tier II assessment, including commissioning and supervision of 5-batch analysis.
- Study Generation support by commissioning and supervising generation of data is done using the appropriate test methods, recognised by the authorities for the positive evaluation of your products (physical and chemical testing, toxicological and ecotoxicological, environmental behaviour, efficacy). We liaise with reliable and reputable Contract Research Organisations (CROs).
- Advice on the data requirements in place in different countries of the regions we are covering, with all the nuanced differences and local specifics which need to be taken into consideration for successful registration of your products.