Biocide Dossier Preparation And More
Our multidisciplinary regulatory affairs support team has many years of experience in chemistry, efficacy, environmental fate, ecotoxicology, and human toxicology to help with biocide products regulation (BPR) testing and biocide dossier preparation/registration. You can benefit from our well-established links with authorities, industry, and working groups to stay informed on any regulatory changes and scientific developments, and to keep registrations compliant and on schedule, easing the burden on your team.
The regulatory landscape for biocides is complex, and without regulatory affairs support, it can be difficult to navigate biocide testing and the registration maze to know what is required for seamless biocide dossier preparation and submission. Working with Charles River’s biocidal products regulation (BPR) registration consultants can help you get it right the first time.
WEBINAR SERIES
Advance Your DART Programs with New Approach Methodologies (NAMs)
Join us for a two-part webinar series that will explore how chemical companies can strategically integrate NAMs and in vitro methods into testing and development workflows. Learn More
Planning Your Biocide Products Regulation Testing and Registration
Our BPR support can be tailored to your requirements. We can provide a wide range of services from ad hoc consulting up to a full registration package – to optimize your internal resources, manage multiple biocide testing programs, ensuring seamless coordination between testing and regulatory needs, and reducing time to market. Our biocide products regulation services include, but are not restricted to:
- Pre- and post-submission regulatory consultancy regarding biocide testing strategy and study design (including in silico assessment, read-across, and other New Approach Methodologies [NAMs])
- Data gap analysis and data waiving, collection, and evaluation of existing biocide testing data against regulatory data requirements
- Preparation of regulatory dossiers in IUCLID for active substances and products (single products or biocidal product families) or parts thereof and submission
- Biocide dossier preparation – in IUCLID and for Assessment Reports
- Contact with regulatory authorities, as point of contact and/or subject matter experts
- Project coordination/management and study monitoring
- Same Biocidal Products Regulation submissions
- Writing of scientific and/or regulatory documents (e.g., expert statements, position papers, justifications on decisions, manuscripts for peer-reviewed journals)
Besides regulatory consultancy and biocide dossier preparation services, our regulatory affairs support can also offer the following activities:
- Design, monitoring, and assessment of efficacy studies and evaluation against regulatory requirements
- Exposure modelling and risk assessment for human health, animal health, and the environment, including higher tier refinements, as well as exposure modeling for animal health
- Assessment of endocrine-disruption properties (ED) according to EFSA/ECHA Guidance for the identification of endocrine disruptors, including consultancy literature search, biocide testing strategy, data evaluation, (non-endocrine) mode of action analysis and hazard identification
- Evaluation of (Quantitative) Structure-Activity Relationship ((Q)SARs) and read-across (such as DEREK, SARAH, Leadscope, OECD QSAR Toolbox, ECOSAR etc.,)
- Dermal absorption assessment based on in silico models
- Assessment of technical equivalence of approved active substances
- Preparation of safety data sheets (SDS)
- Preparation of summary of product characteristics (SPC) in IUCLID
- Classification and labeling (CLP and CLH)
- Literature searches
- Training
To discuss your requirements with our BPR experts and plan your route to biocidal registration get in touch.