Regulatory data dossiers

As well as providing efficacy data to support products under schemes such as the EU Biocidal Products Directive (BPD), IMSL has a sound understanding of both what is required and how the claims you make impact on this both in the EU and worldwide. Through internal expertise, as well as a network of highly respected consultants, we can help identify what is required to support your product and contribute to the production of the dossiers where necessary.

 

Recent changes to the BPD and its conversion to a Regulation in the near future have brought further challenges to supporting biocidal products within the EU. For example, understanding the impact of the data provided by a Letter of Access can be critical to understand if you do not want your competitors to know what you are trying to do. Similarly, the impact of sourcing your active substance from more than one supplier can have significant implications to the support of a final biocidal product. Many seemingly minor changes will potentially have significant implications for many product types such as the effect the special attention being paid to dermal adsorption could have on treated textiles.