Pharmaceuticals in the Environment

As a leading research laboratory in environmental testing, you will have access to unrivalled expertise to assist with Environmental Risk Assessment for your pharmaceutical compounds.

The European Medicines Agency (EMA) requires that an Environmental Risk Assessment (ERA) is completed as part of every Marketing Authorization Application (MAA) for pharmaceutical products.

This process is usually completed during clinical development Phases II/III to ensure that the potential effects of the pharmaceutical on the environment are understood and that adequate precautions can be taken if specific risks are identified.

At Fera, we offer decades-long experience in environmental testing combined with deep regulatory expertise. Our team of scientists can guide you to the best and most efficient risk assessments for your product, which are performed to the highest standards in our state-of-the-art GLP facilities.

Our Services

We can support with the design and delivery of studies at every step of the ERA process.

Find out more about our specific services across Physico-chemical Properties, Ecotoxicology and Environmental Fate, below:

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Physico-chemical Properties

Physico-chemical property testing characterises the inherent properties of a molecule, which is necessary to support the design of subsequent experimental studies and can contribute to environmental exposure modelling.Ecotoxicology testing, includes:

We are equipped to design and deliver a broad range physico-chemical property studies according to your needs:

Ecotoxicology

Ecotoxicology studies examine the effects of chemical compounds on non-target organisms. The goal of ecotoxicology testing as part of the pharmaceutical risk assessment process is to determine the concentrations at which pharmaceuticals pose an acceptable hazard to the environment, so that these levels can be compared to anticipated exposure concentrations following use.

Ecotoxicology testing, includes:

Aquatic ecotoxicology studies

Examine the potential impact of a compound on aquatic species across the different trophic levels – fish, invertebrates (such as Daphnia) and primary producers (such as green algae and cyanobacteria).

Studies can be performed on both pelagic and benthic taxa.

Terrestrial ecotoxicology studies
Examine the potential impact of a compound on terrestrial species across the different trophic levels – micro-organisms, invertebrates (such as earthworms) and higher plants.

Endocrine disruptor studies
Evaluate a compound’s potential to alter the endocrine systems of aquatic species, which can impact their reproduction and development. In recent years, there has been increasing concern around endocrine-disrupting effects, leading to the inclusion of data requirement for tailored assessments for the aquatic compartment.

At Fera we are equipped to design and deliver a broad range ecotoxicological studies according to your needs.

Environmental Fate

Environmental fate studies examine the behaviour of pharmaceutical compounds in different environmental compartments and help estimate the environmental exposure of the compound and its potential degradation products in soil, sediment, surface water and groundwater.

Degradation studies are performed in a range of environmental compartments to generate information on the rate of degradation as well as the pathway of degradation, often using radiolabelled test chemicals. Subsequent analysis can be performed to elucidate the structural identity of degradation products that may be formed.

Adsorption/desorption studies are used to generate information on the mobility of a compound in the environment and can be used to estimate the potential movement from the site of entry into other environmental compartments.

At Fera we are equipped to design and deliver a broad range environmental fate studies according to your needs.