Support is our number one priority.
Whether launching new into the market or managing compliance long term, we know the ins and outs so you don’t have to.
How can we support you?
Regulatory Compliance
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REACH is the regulatory system for managing safe manufacture, supply and use of chemicals in the EU, with other systems worldwide now applying similar principles. Building on many years of experience and over 200 lead registration dossiers, Vitis Regulatory can support you with the development of all aspects of technical dossiers, including substance identity and classification and labelling, and response to regulatory evaluation.
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In compiling product authorisation dossier(s) for compliance with the EU Biocidal Products regulations and similar regulations in the UK, Vitis Regulatory applies its understanding of the complex needs of the regulations for active substance and product assessment , which is essential for both regulatory acceptance and cost savings. We have expert knowledge of chemistry, degradation in the environment, toxicology and ecotoxicology, and partner with other experts for assessment of efficacy.
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Beauty should not come at the cost of human health or environmental safety. The Vitis Regulatory team’s understanding of chemistry, degradation in the environment, toxicology and ecotoxicology allows us to support development of the cosmetic product safety report (CPSR) for notification under the EU Cosmetics Regulation.
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Where possible, risk assessments should reflect realistic conditions of use, and current practices in industry. Vitis Regulatory can model exposure at all steps of the supply chain, quantifying how the environment and humans may be exposed to a chemical throughout its life cycle. We can also assess exposure in depth for specific locations, using modelling to help plant managers identify operational controls they can apply to minimise environmental footprint.
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Scientific Research
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Where data for regulatory submissions are missing, it can be possible to use different techniques to fill data gaps including quantitative structure-activity relationships (QSAR), read across and alternative methods to testing.
Vitis Regulatory has extensive experience of developing project-specific QSAR models as well as augmenting and validating existing off-the-shelf methods for specific substances.
We can provide all the necessary documentation to fulfil regulatory compliance needs for the use of predicted data.
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Vitis Regulatory has wide experience in the use of standard and bespoke modelling methods and programs for assessment of environmental exposure and fate, worker and consumer exposure, including impact of market changes.
We also work with clients and laboratory-based partners to validate models using measurements from workplace monitoring, effluent and environmental monitoring data and experiments.
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Vitis Regulatory has a strong team of analytical chemists, skilled in substance identity and sameness evaluation for regulatory purposes. We have significant experience in the characterisation of complex substances such as UVCBs from both natural and synthetic sources.
We can also undertake literature reviews and screening assessments on a wide range of regulatory endpoints including use pattern, fate, toxicity and endocrine disruption.
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With ever-increasing requirements for complex regulatory testing in environmental fate and (eco)toxicity, Vitis Regulatory experts support our clients and their selected contract laboratories to design and monitor testing programs and studies that are fit for purpose.
Our team has deep understanding of the challenges associated with testing “difficult” substances including volatiles, poorly soluble or unstable substances and complex mixtures.
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Chemicals Policy
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Vitis Regulatory works with government and government agency clients to support the development and analysis of policy for chemicals management. Our skill set is centred on understanding the risk of substances and the impacts they have, such that the consequences of regulatory actions can be quantified, and the costs and benefits understood. We are proud to have played a key role in the development of research for the EC, ECHA and the UK Government Agencies.
