Biocides

Regulatory support for biocidal active substances and products under the Biocidal Products Regulation (EU) No 528/2012 (BPR) and other frameworks, in Europe and internationally: notifications, dossier preparation and exchanges with authorities.

• *Dossier Preparations
  Detailed preparation of regulatory dossiers for biocidal products

• *Data Gap Analyses (DGA)
  Analyses of data gaps in biocide submissions and how to close them

• *International Uniform Chemical Information Database (IUCLID)
  IUCLID dossiers for biocidal active substances and products

• *Applications and Exchanges with Authorities
  Applications and follow-up with authorities, including R4BP submissions under the EU BPR

• *Poison Center Notification (PCN)
  Poison centre notifications for biocidal products

• *Unique Formula Identifier Generation (UFI)
  UFI generation, including links to mixture information (MiM: mixture in mixture) for biocides

• *Risk Assessments (RAs)
  Risk assessments for biocides: health, environment, combined and secondary risk assessments

• *Global Efficacy Services
  Simulated-use and field testing for biocides, taking NAM (New Approach Methodologies) into account

• *Efficacy Coordination and Monitoring
  Coordinated and monitored efficacy testing for biocides, including Good Experimental Practices (GEP)

• *Coordination and Monitoring of Laboratory Testing
  Regulatory support for biocide laboratory testing, including GLP and non-GLP testing

• *Study Monitoring of all types and Dossier Monitoring
  Monitoring of regulatory studies and dossiers for biocides, from protocol to final report

• *ED Assessments
  Endocrine disruption assessments for biocides

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• Contact us to discuss your biocide dossier