- Management of international cross-functional project teams
- Management of registration process (primarily EU) for:
- New products
- Maintenance, label changes
- Re-registrations, Annex I renewals (AIR 1, AIR 2. AIR3 etc)
- Study management, including
- Study design and Study Monitoring
- CRO liaison
- Expert interpretation
- Report review and potential regulatory impact of results/conclusions
- Specialist areas include genetic toxicology, inhalation toxicology, reproductive and developmental toxicology, pathology, neurotoxicology, DMPK and environmental/ecotoxicology and environmental fate. See our expertise page for details
- Extended literature search, followed by review of relevance and reliability, following ECHA Guidance on information requirements and chemical safety assessment.
Data Gap assessment
- A key early stage assessment for which the RSA team is extremely well equipped to prepare:
- Expert analysis of the database available (critical in defining how the data requirement for each endpoint will be met)
- Effectively defining the technical strategy
- Projecting costs, for the whole project at an early stage.
- Determining application procedure under the BPD (Dir. 98/8/EC) and the new Biocidal Products Regulation
- Data requirements for the Product Type you wish to register
- Completion of application forms, including via R4BP
IUCLID and CSR Dossier preparation
- Keeping dossiers submitted to ECHA up-to-date.
- Population of IUCLID technical chapters of physical and chemical properties, environmental fate and pathways, ecotoxicological information and toxicological information.
- physical chemistry
- environmental fate
- critical endpoints – DNELs/PNECs
- classification and labelling
- exposure assessment
- risk characterisation
- Review of data requirements for each substance or category
- Identification of previous regulatory reviews, world-wide.
- Preparation of initial data gap analysis based on proprietary information, any previous regulatory reviews and up-to-date open literature information.
- The combined experience of our expert group identifies the potential read-across candidates and considers the scientific integrity of addressing endpoints using a weight of evidence approach before finally updating the data gap analysis.
- Formulation of any study requirements to address an endpoint that cannot be otherwise addressed.
- Individual experts in all major toxicological disciplines, such as assessment of Endocrine Disruption potential.
- Dossier updating at the request of ECHA or by submission of new information on the registrant’s own initiative.
- Combined Advocacy, liaison and representation with regulatory authorities.
- Establishing mode of action (MOA) in animals and relevance to humans
- Investigative toxicology and mechanistic problem solving
- Authoring scientific publications and position papers
- Regulatory support to maximise product lifespan and develop opportunities
- RSA helps clients plan and prepare Annex XV dossiers on harmonised classification and labelling. This includes liaison with Member State Competent Authorities, in particular where submission needs to be via an MSCA as is the case for amendment of existing Annex VI classification.
- For clients requiring support for human health assessment questions arising for substances included in the first Community Rolling Action Plan (CoRAP), RSA provides specialist consultancy, including assessment of potential for endocrine disruption, CMR issues and STOT-RE classification.