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REACH Chemicals in Pharma Production

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TThe manufacture of medicinal products involves a range of substances such as precursors, intermediates, excipients, and process chemicals. EC Regulation 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) requires the registration and providing information on the chemical safety for these substances to 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 experience from the Danish Environmental Protection Agency and extensive knowledge of REACH regulation 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

Delivery

SAXOCON compiles a written report comprising the toxicological information necessary for fulfilling REACH requirements.

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EC Regulation 1907/2006 compliance.