W330 S3210 Bryn Mawr Road
Dousman, WI 53118
Voice: 262.968.9313
Services
- Comprehensive product labeling, ingredients and claims reviews against FDA, CPSC and Health Canada regulations including Drug Facts Box
- Auditing of analytical and microbiological laboratories and contract manufacturers for qualification and cGMP compliance
- Problem solving for formulation and microbiological contamination issues
- Assistance with FDA 483 and Warning Letter Resolution
- Provide Targeted and Ongoing Regulatory Expertise
- Technology Transfers
- Support for Various Regulatory Registrations
- Provide Support & Interpretation of Testing & Documentation for Retailer’s Compliance and Testing Programs including CPSIA and Health Canada Consumer Product Safety Act
- Assistance with California’s Prop 65, VOC (Volatile Organic Compounds) and Safe Cosmetics Regulations
- Preparation and Assistance EU Registrations of Cosmetics
Product Expertise:
- Post Foaming Gels
- OTC drugs: topical antiseptics, sunscreens, skin protectants, dandruff, antiperspirants
- Personal Care products: shampoos, conditioners, body wash, lip products, gels lotions, post foaming shave
- Home fragrance: candles, aerosol and accessories
Subject Matter Expertise:
- FDA cGMPs 21 CFR Part 211 & ISO 22716
- USP 61/62, 51, Preservative System Design & Efficacy
- FDA and Health Canada Labeling Regulations
- CPSIA for Personal Care/Cosmetic Products
- WERCS submissions
- Candle Testing Protocols
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