PROPOSE A TOXICOLOGICAL RISK ASSESSMENT FOR LIFE SCIENCEs PRODUCTS.
SPECIFIC EXPERTISE IN ENDOCRINE DISTURBANCES AND NANOTECHNOLOGIES

Expertise

Thanks to our knowledge and understanding of regulatory prerequisites as well as our experience of toxicological assessment projects, we support our clients in the risk assessment process while respecting their industrial objectives. Our team of experts provides advice, support, data interpretation and risk assessment for your specific ingredients or products.

Our scientific approach to support your business strategy

- Definition of your specifications
- Proposal of personalized support
- Identification of risks
- Management of toxicological risks
- Scientific document writing intended for your specific interlocutors: customers, authorities, stakeholders… etc.

We support our clients facing multiple challenges

- I wish to know the scientific state of the art concerning the safety of use of a product
- I need to calculate the safety margin for the use of an ingredient or a product
- I need scientific elements to respond specifically to informed consumers who are inquiring about the composition of my product
- I need an expert in toxicology to help my legal department to draft registration files or PIDs
- I need help defining a toxicological studies strategy in order to submit a market approval request
- I need help communicating with subcontractors (CROs) to identify the tests needed to meet regulatory requirements and characterize risks
- I am developing a test to assess endocrine disrupting effects and I would like to have it validated by the authorities.

Process

Human toxicological risk assessment

At LifeScientis, products are evaluated in their context of use by combining different scientific approaches. Our approach takes into account the particularities of the products and the constant evolution of scientific knowledge. It promotes transparency and the presentation of all critical information and all relevant explanations in order to reduce doubt and uncertainty.
1/4
Information gathering

Bibliographic analysis  

In silico analysis

Substance Characterization  

Appraisal of existing information and gap analysis  

2/4
Hazard assessment

Collection of hazard data 

NAM (new alternative methods) 

Physicochemical properties  

Pharmacokinetics and pharmacodynamics 

Toxicological outcomes 

Benchmark/threshold limits 

AOP (adverse outcome pathway) 

3/4
Exposure Assessment

Exposure scenario 

Specific populations 

Local and systemic exposition 

 

 

 

 

4/4
Risk Characterization, Monitoring and Mitigation

Risk assessment tools

(Margin of Safety, Acceptable Daily Intake, Occupational Exposure

Limit…) 

NGRA (New Generation Risk Assessment) 

Weight of evidence 

Regulatory compliance & foresight 

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