Cambridge Environmental Assessments (CEA) provides specialist regulatory support and consultancy to industry clients seeking approval of their active substances and authorisation of their biocidal products. We have a wide range of experience with various product-types and can offer expert guidance on the requirements of EU 528/2012, the Biocidal Products Regulation (BPR).
Because of our multidisciplinary expertise and building on our track record of higher tier environmental risk assessment, CEA can provide a full dossier preparation and support service under the BPR, throughout the entire regulatory process, including:
- Advocacy meetings with Member State regulators
- Data gap analysis
- Literature reviews
- Placement and monitoring of studies
- Environmental risk assessment
- Human health risk assessment
- Dossier preparation (IUCLID 6 and SPC Editor), submission (R4BP 3) and follow-up
- Responding to questions from Member State regulators
- Preparation and presentation of position papers
- Software development
Please contact us to discuss your biocide needs.