Regulatory Science Associates
About us
Regulatory Science Associates (RSA) is an expert consultancy group of highly qualified and reputable toxicologists and regulatory affairs specialists, based throughout the UK and Europe. An enthusiastic and committed group, we specialise in techno-regulatory support with particular focus on issues relating to human health which impact classification and labelling, hazard and risk assessment including DNEL derivation (REACH). RSA is experienced in technical dossier compilation, in particular within the context of REACH. Our clients include blue chip companies, CROs and major European Consortia.
RSA experts have been providing advice and support to clients since before the first REACH registration deadline in 2010. We have expertise in assessing data completeness, advising on testing strategies including non-testing approaches (waiving and read-across), toxicology study monitoring and CLP classification. RSA can also provide focused services including theoretical toxicokinetic assessments and assessment of endocrine disrupting (ED) potential.
RSA's world-class regulatory consultants are committed to providing you with the correct support that will address and resolve complex issues and achieve regulatory compliance.
As a company we are big enough to include the specialists you need, and small enough to really care about our clients
Products & services
RSA General Chemical Services
RSA experts have been providing advice and support to clients since before the first REACH registration deadline in 2010. We have expertise in assessing data completeness, advising on testing strategies including non-testing approaches (waiving and read-across), toxicology study monitoring and CLP classification. RSA can also provide focused services including theoretical toxicokinetic assessments and assessment of endocrine disrupting (ED) potential.
About RSA
Regulatory Science Associates (RSA) was founded in 2007 as a regulatory science consultancy made up of toxicology consultants, other technical experts and regulatory affairs specialists who bring decades of combined experience from the general chemical, agrochemical, biocide and pharmaceutical industries. RSA's aim is to provide technically robust scientific solutions, supporting our clients in achieving and maintaining regulatory compliance for their products. We are an enthusiastic and dedicated regulatory consulting team with strengths in toxicology consulting, human health exposure and risk assessment, as well as ecotoxicology and environmental risk assessment services. If we can help you please drop us an email to info@regulatoryscience.com
RSA Biocides Services
RSA has a proven track record and long history of working for clients in the EU biocides sector. RSA specialists provide support for biocidal active substance approvals and biocidal product authorisations through bespoke scientific advice, and have expereince in the risk assessment of a number of different product types. RSA can provide a tailored service, from consultation on specific technical issues to managing a programme of activities to support active substance approval or product authorisation under the EU Biocidal Products Regulation.
RSA Study Management Services
RSA offers study management and monitoring services designed to facilitate the successful execution of regulatory and non-standard investigative studies. Our experienced team closely collaboratewith CRO's to manage every aspect of a study, ensuring that timelines and compliance standards are met.
RSA Technical Services
RSA's breadth and depth of scientific and regulatory expertise means that we can offer clients sound advice alongside a range of technical services. With particular strengths all types of toxicology consulting, human exposure and risk assessment as well as ecotoxicology and environmental risk assessment, our aim is to support our clients in achieving regulatory compliance for their general chemical, biocide, agrochemical or pharmaceutical products.
Dossier Preparation
RSA offers expert dossier preparation services designed to streamline the regulatory approval process. Our experienced team ensures that all necessary client documentation is compiled, reviewed and submitted according to the specific requirements. Our services include data gap analysis, risk asessment, study summaries (OECD and IUCLID), CRO Liaison and literature searches.
Endocrine Disruption Services
RSA specialists have extensive experience and expertise in the science of endocrine disruption. Our consultants have participated in ED test method vaidation projects, been representatives on various OECD ED Task Forces and Management Groups as well as ECHA ED Expert Group (EDEG). RSA can provide advice to clients on data completeness and testing strategies for ED under REACH, pesticides and biocides regulations, including an initial ED vulnerability assessment based on existing proprietary and published data, HTS and (Q) SAR. We can provide support through the regulatory process, including preparation of full ED assessments (Appendix E and I), MoA analysis for regulatory submission, client representation and support during commenting or consultation periods.