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Active substance & Product Registration dossier: biocides

Registration dossiers for active substances and products biocides logo

We can assist you with the following, for either chemical and biological products or active substances: 

  • Advising on the optimum strategy, including Union Authorisation (UA), Mutual Recognition (MR) and Same Product procedures
  • Data Gap Analysis – to identify the required studies, costs and timeline
  • Preliminary Risk Assessments
  • Literature Search, bridging data, expert statements
  • Study Placement, Generation & Monitoring (GLP)
  • New Active Substance dossiers
  • Application for “Article 95” inclusion (list of authorised suppliers of active substances)
  • Technical equivalence applications for new sources of active substance
  • Product Registration dossiers, including Biocidal Product Family (BPF) and Simplified Procedure (Art. 25) dossiers
  • Renewal or modification of Product Authorisation
  • Transitional Product Registration dossiers (Art. 89) in all European Member States (including France via SIMMBAD/Anses & SYNAPSE/INRS), governed by the national provisions in force in each MS
  • International registration
  • Pre-submission meeting with competent authorities
  • Risk Assessment refinement
  • Writing of study summaries via IUCLID
  • Writing of Product Assessment Report (PAR)
  • Producing of the Summary of Product Characteristics (SPC) via SPC Editor
  • Dossiers submission and follow-up with competent authorities via R4BP Platform

You want to build your registration dossier in another business area?