Full dossier support

Full dossier support

A thorough understanding of a substance’s properties, use pattern and exposure pathways is necessary to demonstrate safety to human health and the environment. Because of our multidisciplinary expertise, CEA can provide a full dossier preparation and support service including:

Data gap analysis and expert review

Area of support:

Examples of services:

Identifying data gaps

Expert review of existing data packages against regulatory requirements and identification of data gaps


Review of draft reports


Advice on interpretation of results and conclusion


Satisfying information requirements


Advice on whether to fill data gaps with expert statements/waivers or new studies


Preparation of robust study summaries, expert statements and waivers


Planning and monitoring of higher-tier studies


Field fate and higher tier aquatic ecotoxicological studies (laboratory and mesocosms) conducted in-house


Advice on study design and commissioning


Monitoring of experimental phase


Risk assessment

Area of support:

Examples of services:

Human health and environmental risk assessments


Human and environmental exposure modelling including higher tier solutions (e.g. FOCUS modelling)


Human safety, hazard and risk assessment


Endocrine disruptor evaluation


Expert analysis of fate endpoints and kinetic analysis


Advice on critical endpoints



Regulatory submission

Area of support:

Examples of services:

Submit data sharing requests

Preparation of data sharing requests


Prepare a technical equivalence dossier for a new source of active

Technical equivalence assessments

Active substance and/or biocidal product dossier preparation and submission

Dossier preparation (IUCLID 6) and submission (R4BP 3) for active substance, single biocidal product family dossiers including the Summary of the Product Characteristics using the SPC Editor


Preparation and submission of active substance, single product and product family dossiers via R4BP3


Critical review of draft Assessment Reports and peer review documents



Area of support:

Examples of services:

Liaising with Regulatory Authorities

Support at pre-submission meetings with Authorities and technical working groups


Liaising and meeting with Authorities


Post submission support


Responding to Member State comments



Please contact us to discuss your biocide needs.


Meet the Team

Adrian Terry

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Alan Lawrence

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Fabienne Ericher

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Philippa O’Donovan

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Theresa Neely

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