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Services At A Glance

  • Toxicology consulting and human risk assessment for cosmetic, Over-The-Counter (OTC) drug, and consumer products.

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  • Toxicological testing paradigm and strategy for placing a cosmetic, Over-The-Counter (OTC) drug, or consumer ingredients or products on the market.

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  • Toxicological risk assessment for medical devices focusing on feminine hygiene and incontinence products.

 

  • Consumer Product Safety Report (CPSR).

 

  • Product information file (PIF) review and approval.

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  • Toxicological risk assessment (TRA) for consumer products.

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  • Labeling and claim review. Claim substantiation.

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  • Labeling of Hazardous Art Materials Act (LHAMA) certification.

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  • Cosmetic product listing/notification and facility registration in U.S., Canada, UK and EU.

 

  • Biocompatibility testing and reporting according to ISO 10993 for medical devices.

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  • Drafting of Medical Device Master File (MAF) toxicology section.​

 

  • Chemical characterization of medical devices including extractables & leachables toxicological assessment and study design according to ISO 10993-18.

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  • Toxicological risk assessment of medical devices and tolerable intake determination.

 

  • Globally Harmonized System (GHS) of classification and labeling of chemicals and supporting documentation for U.S., Canada, UK and EU.​

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  • Natural and organic claims based on ISO 16128-1: 2016 and ISO 161-2: 2017.

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