& Medical

ToxMinds toxicologists support companies from the life science industry on many different aspects related to product safety.

Be it the establishment of permitted daily exposure (PDE) levels for actives ending up in a medicinal product through cross-contamination or chemical impurities that stem from the manufacturing process or leached into the product via the drug delivery system, we help ensuring that levels of impurities in medicinal or veterinary products are safe prior to release to the market.  Likewise, our environmental experts have substantial experience in assessing the risks associated with environmental releases of actives or non-actives under manufacturing and use conditions. Our human and environmental safety assessments are conducted using state-of-the art science and are in full compliance with the existing regulatory guidelines.

Our dedicated services for the pharmaceutical, veterinary medicines or medical device sector include:

  • QSAR modelling using ICH M7 recommended tools (e.g., Derek Nexus, Meteor Nexus)
  • Derivation of permissible daily exposure (PDE) levels of active ingredients through cross-contamination in shared facilities
  • Derivation of occupational exposure limits (OEL) for actives
  • Establishment of safe exposure or maximum residue levels of
    • Excipients
    • Manufacturing impurities
    • Extractables & Leachables
    • Other types of contaminants
  • EU chemical regulatory compliance support as applicable to the Pharma sector (e.g., REACH, CLP Regulation)
  • Environmental risk assessment of product ingredients (actives, non-actives)