Supporting and advising our clients as they work to meet regulatory requirements so they can move their businesses forward.
ToxServices’ scientists have years of experience in developing creative strategies and integrating them with published frameworks to help you meet diverse regulatory requirements effectively and transparently.
Specific services include:
- Agency liaison, notifications, and submissions
- Development of toxicity criteria that serve as the basis for regulatory compliance determinations (OELs, NSRLs/MADLs)
- Safety data sheet preparation
- Toxicological risk assessments
- Location- or product-specific substance restrictions/bans
- Analytical test method and test result evaluations within specific regulatory contexts.
- Claim substantiation for products such as dietary supplements and personal care products/cosmetics
- Product label review in support of, for example, Federal Hazardous Substances Act requirements
- Development of test strategies, including use of risk assessment and non-animal methodologies to meet regulatory requirements in lieu of animal testing.
- Resolution of customs holds
- Biocompatibility assessment
- Data gap analyses
- Raw material, supply chain, and finished product/formulation evaluations
- GLP audits
- Quality system audits (ISO 9001)
We have provided regulatory compliance services for the following product types:
- Electronics
- Container closures
- Medical devices (ISO 10993)
- Food additives, dietary ingredients
- Food contact materials
- Dietary supplements
- Consumer and household products
…for the following specific regulations:
- Toxic Substances Control Act/Frank R. Lautenberg Chemical Safety for the 21st Century Act
- Clean Water Act
- Clean Air Act
- Federal Hazardous Substances Act
- Federal Food, Drug, and Cosmetic Act
- Dietary Supplement Health and Education Act
- Food Quality Protection Act
- Consumer Product Safety Improvement Act
- Regulation (EC) No. 1271/2008 on Classification, Labeling, and Packaging of Substances and Mixtures (CLP)
- Regulation No. (EC) 1223/2009 on Cosmetic Products
- California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)
- Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)
