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
- Estimation of safe threshold, i.e. Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL)
Toxicological evaluation of impurities
- Collection and review of published literature of toxicological data to trace the toxicological profile of chemicals
- In silico predictions and Threshold of Toxicological Concern (TTC) approach
Biological evaluation of medical devices performed according to ISO 10993-1 guidance
- Collection and evaluation of the existing data
- Datagap analysis and Biological Evaluation Plan (BEP)
- Contracting and monitoring of new studies
- Risk Assessment and Biological evaluation Report (BER)
Assessment of leachables and extractables
Risk assessment following to quality issues, i.e. contamination, in the lifecycle of pharmaceuticals/medical devices
Environmental Risk Assessment
- ERA report
- Assessment of potential environmental impacts of active pharmaceutical ingredients in wastewater from manufacturing operations
Toxicological and Eco-toxicological consulting
- Dossier strategy evaluation to identify the studies needed to fulfil regulatory requirements Contracting out and monitoring of new tests and report review