Services

Our Services on Biocides

For the registration of your Biocidal Active Substance or Product according to the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) we support you with the following services:

  • Defining the Regulatory Strategy including Data Gap Analysis & Preliminary Risk Assessments

  • Complete dossier preparation (IUCLID & SPC Editor & draft Assessment report biocidal products or active substance)

  • Applications for inclusion in the list of active substances suppliers (Article 95 list)

  • All usual application submissions via R4BP3 (Register for Biocidal Products) and under national requirements (BPR)

  • R4BP3 Account Management/Dossier submission manager

  • Technical Equivalence applications

  • National applications under transitional scheme in several EU countries incl. poison centre notifications

  • Dossier defence activities

  • Meetings with authorities, contract institutes and clients

  • Human and Environmental Risk Assessments

  • Efficacy claim checks

  • Scientific support/Study Monitoring

  • Data Sharing Inquiries

Guiding you safely...

You have specific questions or wish to get to know more about our services?

Let us know how we can support you.

Kerstin Schrade

Lead Regulatory Affairs Manager for Biocides is looking forward to receiving your email.

 

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