Pharmaceutical, Medical Device, Antimicrobial, and Consumer Product Manufacturing, Labeling, Distribution, and Disposal
- Counseling pharmaceutical manufacturers, logistics providers, and forward and reverse distributors on pharmaceutical waste characterization, management, transportation, and disposal; the EPA’s Management Standards for Hazardous Waste Pharmaceuticals; DEA Disposal Act compliance; and federal and state licensure matters.
- Advising health care facilities on pharmaceutical and medical/infectious waste management.
- Providing EPA and FDA counsel as companies develop and market antimicrobial consumer products, coatings, treated textiles, medical devices, air filters and purifiers, disinfectants and sanitizers.
- Providing label compliance and import advice to manufacturers, private labelers, and distributors of disinfectant and antiseptic wipes.
- Counseling consumer products companies on the development of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) exempt treated articles and minimum risk pesticides.
- Providing strategic advice on cosmetic and consumer product development, marketing, and acquisitions, including compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA), Fair Packaging and Labeling Act (FPLA), Proposition 65, FTC Green Guides, organic standards, and country of origin labeling.
- Assisting in developing and implementing CBD and cannabis management and disposal policies and procedures.
- Providing strategic advice to drug manufacturers on compliance with pharmaceutical take-back ordinances.
- Spent more than 100 days inside pharmaceutical API, intermediate, and finished drug product manufacturing facilities in the U.S. and Europe managing FDA inspections, counseling on good manufacturing practices (GMP), and implementing significant remedial actions.