Environmental Risk Assessment for Pharmaceuticals
Pharmaceuticals can enter the environment through several pathways, including wastewater discharge following human or veterinary use, manufacturing effluents and improper disposal of medicines. As a result, there is the potential for pharmaceuticals to adversely affect organisms in the environment that have metabolic pathways and receptors similar to those targeted by pharmaceuticals in humans. Environmental Risk Assessments (ERAs) can be used to assess the potential impacts that an active substance in medicinal products may have on the environment. ERAs are a legal requirement for all new marketing authorisation applications (MAAs) for human medicines in the European Union (EU) and are conducted in accordance with the European Medicines Agency (EMA) Guideline on ERAs of Medicinal Products for Human Use.
How Intrinsik can help
Intrinsik’s multidisciplinary team of risk assessors, toxicologists and regulatory professionals can provide end-to-end support for ERAs for pharmaceuticals in the EU. Supported by our robust company systems and proactive communication with our clients, we help facilitate regulatory compliance and approval in a cost and time effective manner. Our partnerships with commercial laboratories in Europe, North America and Asia allow for a flexible and smooth testing and submission process.
Intrinsik’s services
- Completion of Phase I and Phase II risk assessments
- Completion of preliminary and definitive hazard assessments (PBT/vPvB assessments)
- Determination of required ERA studies
- Laboratory coordination for the initiation and completion of ERA studies
- Preparation of technical ERA report consistent with EMA guidance
- Integration of risk assessment results with risk management
- Technical support during regulatory review