As soon as the (existing) active substances used in your biocidal products are positively evaluated in the context of the Biocidal Product Regulation, (BPR, EU 528/2012), they can be or continue to be marketed for the specified product category. However, a product dossier needs to be submitted in order to get approval for your specific product type in one or more European countries, or union authorization in case your product is applied for? all EU markets. Although the active substance dossier contains most of the necessary information, the development of the product dossier can still be a major challenge, especially in cases where several active substances are used.
With our experience in the development and evaluation of active substance as well as product dossiers, we are ready to assist you with the following activities:
- Data requirement analysis
- Completeness check of any existing biocide dossiers
- Quality assessment of existing data
- Mediate in obtaining a letter of access (if you are not the data holder)
- Prepare a cost-effective test strategy with a minimum of required studies, and clear and scientific based waivers
- The complete risk assessment of your substance and/or products
- Dossier compilation and submission
- Dealing with the CA (Competent Authority) and subsequent comments after submission
With our support you will ensure working in line with the conditions of the regulation.