The manufacturing process for most products involves using a range of substances such as precursors, intermediates, excipients, and process chemicals. EC Regulation 1907/2006 on the Registration, Evaluation, Authorisation, and Restriction of Chemical substances (REACH) requires that the manufacturers, distributors, and sellers of products in the EU provide information about the chemical safety and register these substances with the European Chemicals Agency (ECHA). The information required depends on the quantity of the substance manufactured or imported into the EU.
SAXOCON provides you with everything you need to document REACH compliance with regulatory requirements, including:
- Gathering and reviewing existing toxicological data
- Data gap filling using (Q)SAR and read-across methods
- Submission of data via IUCLID
Why choose us?
SAXOCON services for the manufacture of pharmaceutical products give you access to:
- Toxicologists with extensive knowledge of REACH regulations and EU Classification and Labelling of chemical substances
- Best in class experience in using computational toxicology, including (Q)SAR modelling and read-across methods
- Extensive experience with IUCLID submission and other REACH-IT solutions
SAXOCON compiles a written report comprising the toxicological information necessary for fulfilling REACH requirements.