Regulatory data dossiers

As well as providing efficacy data to support products under schemes such as the EU Biocidal Products Regulation (BPR), 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.

 

Changes introduced during the conversion of the Biocidal Products Directive (BPD) to the BPR 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 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 have had significant implications for many product types.  Similarly, generating the appropriate efficacy data, that is compliant with current and emerging guidance, is critical to successful registration.

 

IMSL has extensive expertise in the generation of efficacy data for regulatory approval, especially for the EU BPR.  We regularly perform studies to support both active substances and biocidal products in Main Group 1 and Main Group 2 of the regulation using a wide range of both standard methods, adapted methods and application / product specific protocols.  IMSL is actively involved in the development of the major methods being applied in this area, especially in Main Group 2 such as IBRG PDG16-007, IBRG PDG16-001 and IBRG P16-001 for Product Type 6 and IBRG FFG16-001 for Product Type 13.  Adaptations of these as well as ASTM E-645 can be used to provide data for Product Types 11 and 12.  A wide range of approaches is available for other Product Types such as PT 7, PT9 and PT10.