With more than fifteen years of experience in the fields of environmental fate and ecotoxicology of crop protection and biocidal products and a dedicated environmental expert group, we can assist you with scientific and regulatory support for the Environmental Risk Assessment of your pharmaceuticals (human or veterinary drugs) and to generate data or –if applicable- waiver which will successfully meet the regulatory requirements of Europe.

Study Conduction

GAB Consulting is highly experienced in scoping, contracting and monitoring environmental and ecotoxicology studies as they are part of the requirements for the environmental risk assessment for plant protection products, biocides and chemicals. The environmental and ecotoxicological testing of pharmaceuticals is carried out according to the latest guidelines to generate the information required for regulatory compliance under the current regulations. We are keen to provide you with competent scientific support during all stages of environmental testing. We are in contact with the best laboratories and research institutions who will conduct studies using the most up-to-date guidance and accurate techniques. Together with them, we also develop suitable designs for complex experimental issues and produce high quality reports, which prevent unnecessary investment of your time and money.

Preparing Environmental Risk Assessments

GAB Consulting has more than 15 years of experience in the fields of environmental fate and ecotoxicology of plant protection and biocidal products. GAB Consulting’s expertise in the preparation of Environmental Risk Assessments for the separate categories of industrial chemicals and biocides as well as our other business areas offers you the best service to comply with the requirements for an Environmental Risk Assessment. Our experts can assist you in the preparation of environmental evaluations and negotiations with the relevant authorities. In addition to the preparation of Environmental Risk Assessments, we constantly monitor the developments of the regulatory affairs assuring an exhausting fulfilment of your obligations.

Regulatory Aspects

In 2006, the guideline on the environmental risk assessment of medicinal products for human use came into force. Since then, the assessment of the environmental impact of medicinal products is a legal obligation and must be performed to evaluate and limit potential adverse effects of medicines on the environment. In accordance with Article 8(3) of Directive 2001/83/EC the evaluation of the potential environmental risks posed by pharmaceutical products should be submitted and their environmental impact should be assessed.

Such Environmental Risk Assessment (ERA) is required for all new marketing authorisation applications for a medicinal product through a centralised, mutual recognition, decentralised or national procedure.

Based on its broad experience in the field of environmental sciences of agrochemicals and biocides, GAB Consulting can offer services to assess the potential risk of pharmaceutical products to the environment including the full range of environmental fate and ecotoxicity testing required in Phase II of the tiered approach.