Chemical risk assessment (PDE, OEL)
TKT routinely deliver Permitted Daily Exposure (PDE) assessments to national and international clients. The accumulated production is now in excess of 170 PDE-reports/different APIs. The PDE:s are prepared and reported in compliance with the “European Medicine Agency’s (EMA) guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”.
For any PDE requested by the customer, TKT ensures a cost-effective solution, as well as a timely delivery, of this critical document in the manufacturing and release of an API.
Likewise, TKT has vast experience in industrial hygiene risk assessment and occupational exposure limit (OEL) settings. Currently close to hundred reports has been produced to national and international customers.
Toxicological supports in the registration of chemicals under the REACH regulation, e.g. compilation of available toxicological information, identification of information gaps (gap analysis), assessment of opportunities for read-across (comparisons with across substances) and preliminary classification.