In partnership with:
Thanks to a long partnership with a specialized team in the pharmaceutical field and our personal expertise in the risk assessment, we are able to offer a wide range of services in toxicological consultancy.
In particular, we support our clients in fulfilling their obligations, along the lifecycle of pharmaceuticals / medical devices / herbal medical products.
SERVICES
- Human health risk assessment and estimation of safe threshold, i.e. Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL)
- Toxicological evaluation of impurities to identify main concerns in order to be compliant with ICH guidelines, e.g. M7 (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk), Q3A (Impurities in new drug substances), Q3B (Impurities in new drug products), Q3D (Guideline for elemental impurities) and Q6A (Specifications test procedures and acceptance criteria for new drug substances and new drug products: chemical substances)
- Assessment of leachables and extractables in packaging delivery systems
- Risk assessment following to quality issues, i.e. contamination, in the lifecycle of pharmaceuticals / medical devices
- Environmental Risk Assessment (ERA) report
- Reviews of published literature of toxicological data and evaluation of toxicological profile
- In silico predictions and Threshold of Toxicological Concern (TTC) approach
- Dossier strategy evaluation to identify the studies needed to fulfill regulatory requirements
- Contracting out and monitoring of new tests and report review
- REACH registration of pharmaceutical intermediates (on-site isolated > 1 t/y, transported isolated 1-1000 t/y and transported isolated > 1000 t/y)
- Biological evaluation of medical devices performed according to ISO 10993-1 guidance