Biocides & Animal Health
KAELTIA offers the full range of services required for the registration of biocidal active substances and products in Europe (Regulation 528/2012) and under National framework in Europe and overseas.
KAELTIA offers their services for the product registration of animal health products such as animal health biocides (insecticides, disinfectants, repellents, rodenticides..) according to the EU and National framework (in Europe, during the transitional period, and overseas), and veterinary medicines/pharmaceuticals according to the requirements of Directive 2001/82/EC.
KAELTIA´s scientists have been involved in the production of dossiers for several product types and can help your company to comply with the specific requirements of your products:
– Data gap analysis and preliminary risk assessments
– EU dossiers in accordance with Regulation 528/2012 in the IUCLID format for biocidal active substances and products and submission via R4BP
– Technical equivalence dossier for new active substance source
– National registration of biocidal active substances and products in Europe (during the transitional period) and overseas
– Preparation of EU mutual recognition applications
– Development of rationales for study waivers and expert statements, where possible
– Toxicological, environmental, livestock and dietary risk assessments
– Modelling and development of exposure scenarios
– Study commissioning and monitoring
– Task Force or Consortia coordination
– Liaison with the Authorities
– Follow-up of the registration process