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

 

Stewardship

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

 

 

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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