Your company has a formulated product which it believes is of good quality and suitable for placement on the EU market. You might have already placed the product on the market outside of the EU and are looking for advice on what needs to be done to also introduce the product to the EU market and information on the required financial investment.
If you are already present in the EU market and you are looking for ways to enter non-EU markets, we can provide the necessary support or put you in touch with local experts who can offer further guidance and support.
We offer the following services:
- Preliminary Assessment of your portfolio or individual products taking into account the EU status of your substance as well as data protection rules. We prepare a data gap analysis (DGA) by indicating what studies need to be generated to comply with the data requirements for your substance/formulation and also estimate the cost of study generation
- Support by acquiring an Equivalence Assessment of Active Substances and help preparing 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 the generation of data is done via the appropriate test methods, recognised by the authorities for the positive evaluation of your products (physical and chemical testing, toxicology and ecotoxicology, environmental behaviour, efficacy). We liaise with reliable and reputable Contract Research Organisations (CROs)
- Counselling on the data requirements in place in different countries of the regions that we cover with all the nuanced differences and local specifics which need to be considered for the successful registration of your products