Europe
The BiochemAlliance partners in Europe are EuroChemLink Ltd, Cambridge Environmental Assessments and ForthTox Ltd. We offer a comprehensive range of problem solving skills relating to chemicals and chemicals regulation that can be tailored to your needs.
Biocidal Products
We provide integrated resources to assist with the registration of biocidal products under Directive 98/08/EC including exposure scenario definition, risk assessment and the preparation and submission of BPD dossiers.
Key skills
- Data evaluation and identification of data gaps
- Preparation of dossiers in IUCLID format
- Placement, monitoring and assessment of all studies needed for meeting the requirements of the directive, including all toxicity and environmental studies
- Expert, professional management of industry task forces
- Development of emission scenarios and exposure pathways
- Application of environmental fate and exposure models (EUSES, FOCUS, GREATER)
- Fate and ecotoxicological assessments
- Professional toxicologist support and review, based on more than 30 years experience.
Contact d.lahoda@eurochemlink.com or paul.mason@cea.adas.co.uk
Agrochemicals
BioChemAlliance partners EuroChemLink and Cambridge Environmental Assessments have wide experience in the provision of support for clients to meet regulatory requirements under the Authorisation of Plant Protection Products Directive 91/414/EEC, both for Annex 1 inclusion and Member State registrations.
ForthTox provides toxicological back up through the placement and monitoring of all required
scientific studies (field and laboratory) and preparation of toxicological
reviews and other supporting documentation.
Key skills
- Dossier preparation and completeness checks
- Study placement and monitoring
- Human health and dietary exposure risk assessment
- Task force and product management
- Member State registrations
- Modelling exposure to groundwater and surface water
- Evaluation of risks to the aquatic and terrestrial environment
- Refined exposure and effects assessments
- Higher tier aquatic and terrestrial field studies
- Professional toxicologist support and review, based on more than 30 years experience.
Contact adrian.terry@cea.adas.co.uk or d.lahoda@eurochemlink.com or adam@forthtox.com
Veterinary Medicinal Products
BioChemAlliancepartner, Cambridge Environmental Assessments has a track record in assisting clients with VICH environmental criteria for the market authorisation of veterinary medicinal products under Directive 2004/28/ EC, plus an extensive knowledge of fish medicines and their potential for environmental exposure in aquaculture.
ForthTox has broad experience of preparation of non-clinical documentation for submissions for veterinary medicinal products and the conduct of defensive documentation when problems arise. In addition, ForthTox offers Derek predictive software for toxicological evaluation of compounds for lead candidate prioritisation or for genotoxic potential of pharmaceutical impurities.
Key skills
- Determination of PECs in livestock scenarios
- Modeling fish medicines in aquaculture
- Comparative risk assessments
- Refined risk assessments
- Regulatory support
Contact paul.mason@cea.adas.co.uk or adam@forthtox.com
General Chemicals and REACH
BioChemAlliance partners, EuroChemLink, CEA and ForthTox are able to support clients in meeting the needs of general chemicals regulation and proposed legislation under REACH.
Key Skills
- Reviewing active ingredients and products under the Directives for the classification, packaging and labeling of dangerous substances (Directive 67/548/EEC) and dangerous preparations (Directive 88/379/EEC and 1999/45/EC)
- Gap analysis for compounds, test programme proposals, study placement and monitoring.
- Derek toxicity prediction software for evaluation of chemicals in read-across assessments etc
- Preparation of dossiers required for the review of existing chemicals and the notification of new chemicals.
- Evaluation of environmental criteria in accordance with the Technical Guidance Document.