TOXICOLOGY SERVICES

Basis of our Services

Ø  Companies, based on their core values, intend to sell safe products to sustain the expectations of their customers;

Ø  We believe safe products benefit consumer well-being and health;

Ø  Our services sustain our clients’ core values and promote consumer well-being and health.

 

Services Offered

Ø  Expertise to Build, Expand and Sustain a Portfolio of Safe Products consistent with your companies’ objectives and core values

Ø  Specifically, we provide:

§  Chemical & Ingredient Hazard Evaluations for Product Safety

§  Human Health Safety & Risk Assessments

§  Toxicology Testing Strategy Development

§  Integrated Testing Concepts

§  Toxicology Study Monitoring

§  Regulatory Dossier Preparation

§  Global Regulatory Compliance Support

 

Areas of Toxicological Expertise

Ø  General human health toxicology and risk assessments

Ø  Exposure assessments; Hazard assessments

Ø  Safety & Regulatory compliance for Personal Care Product Ingredients:

o   UV Filters, Hair dyes, Antimicrobials, Polymers, Botanical Extracts

Ø  Engineered Nano-materials safety in cosmetics and foods

Ø  Safety & Regulatory Compliance for Vitamins, Food Additives, Supplements

Ø  Industrial chemical testing; Ingredient safety evaluations

Ø  Certified Cosmetic Ingredient Safety Assessor

Ø  Preparing effective, logical, and convincing ingredient safety strategies and dossiers for Regulatory submission mainly in the EU and USA

Ø Excellent written and verbal English; limited skill in written technical German

James R. Plautz
Senior Consulting Toxicologist

Over 30 years of toxicology experience: the last 20 years with three major chemical manufacturing companies, based in the United States and Europe, ensuring products’ safety and compliance in their global markets of ingredients for Personal Care, Home Care, and Human and Animal Nutrition Products, as well as Drug Ingredients.

Experienced in supporting cosmetic ingredient safety for most all types of substances from synthesis, reformulation, impurities assessments and final product through safety assessment dossier preparation and discussion with Competent Authorities for regulatory approvals. Majority of ingredients were for personal and home care products, including a number of U.S. FDA- regulated ingredients, and Food Additives and Vitamins.

Sixteen years providing toxicology support as contractor to US Regulatory Agencies including US EPA Pesticides Program for registrations review and evaluation; the National Toxicology Program, through NIEHS, as data auditor, and toxicology study reviewer; and as independent consultant to small enterprises ensuring safety and regulatory compliance of their products.

Extensive experience in several US and EU company locations managing large and small contracts, professional staff and project colleagues for effective projects’ completion.

james.plautz@chrysalis-services.ch