Based in Brussels, the heart of the European decision making, the regulatory experts of ToxMinds stay abreast of the regulatory developments applicable to the industry sectors we support.
Our experience is the basis of our registration services. With our in-depth understanding of the data and documentation requirements as well as our knowledge how to perform the state-of-the-art risk assessments, we guide our clients through all necessary steps to achieve compliance with the Regulations for chemicals (REACH), biocides (BPR), consumer and cosmetic products.
Our regulatory services for all our industry clients include:
- Portfolio review and regulatory strategy consulting
- Data compilation, evaluation of non-testing approaches and waiving opportunities, final data gap analysis
- Design and management of testing programmes
- Interpretation, quality evaluation and study summary preparation of physico-chemical, environmental fate, ecotoxicology and human toxicology studies
- Human and environmental exposure modelling, covering occupational, residential and dietary exposures as well all relevant environmental compartments
- Higher tiered human and environmental state-of-the-art risk assessment
- Development of Regulation-compliant registration dossiers or submissions
- REACH Regulation: IUCLID dossiers; Chemical safety assessment and reports
- Biocidal Product Regulation: Development of product authorisation dossiers and R4BP; including documents I, IIA, IIB, IIIA, IIIB and all other supporting documents for the product types
- Cosmetics Regulation: Cosmetic ingredient dossiers for SCCS submission; Product information files (PIF)
- Preparation of responses to authority requests and/or advocating and defending scientific approaches with public authorities (e.g., ECHA, EMA, EFSA, and national authorities)