Farmaceuticals and Medical Devices

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Comprehensive toxicological consultancy: supporting pharmaceutical and medical product compliance

Consulenza tossicologica
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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.

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
REACH registration of pharmaceutical intermediates (on-site isolated > 1 t/y, transported isolated 1-1000 t/y and transported isolated > 1000 t/y)