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Pharmaceuticals

In order to bring a new pharmaceutical product to the market in the EU, a marketing authorisation application (MAA) must be granted by the European Commission after evaluation by the European Medicines Agency. 

A requirement for the MAA, is to demonstrate that the product will not cause harm in the environment. Our specialist team of environmental fate scientists and ecotoxicologists are perfectly placed to perform Environmental Risk Assessments (ERAs), including refined ERA, for human medicinal products.  We have experience in assessing a range of product types. 

Our services include:
  • Regulatory advice and support
  • PBT assessments
  • Calculation of PECSW for Phase I ERA
  • Refinement of market penetration factor (Fpen)
  • Tailored RA for Endocrine Active Substances and antibiotics
  • Data gap analysis
  • Literature search & reliability assessments
  • Study placement, monitoring, and evaluation
  • Tier A Phase II and Tier B (refined) ERA
  • Labelling and risk mitigation recommendations

For further information explore our Service Information Sheet.

 

 


Contact

Enviresearch Ltd
34 Grainger Park Road
Newcastle upon Tyne NE4 8RY

Telephone: +44 (0)191 243 0687
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Further Information

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