Pharmaceutical, Medical Device, Pesticide/Antimicrobial, and Consumer Product Manufacturing, Labeling, Distribution, and Disposal
- Advising health care facilities and medical waste service providers on medical/infectious waste and hazardous waste pharmaceutical management.
- 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 a manufacturer on environmental compliance and enforcement matters pertaining to water and waste from its pharmaceutical manufacturing operations.
- Providing EPA and FDA strategic counsel as companies develop and market antimicrobial consumer products, coatings, treated textiles, medical devices, pesticide devices, air filters and purifiers, disinfectants, and sanitizers.
- Counseling consumer products companies on the development of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) exempt treated articles and antimicrobial, biopesticide, conventional, and minimum risk pesticides.
- Providing strategic advice on cosmetic and consumer product development, marketing, and acquisitions, including compliance with the FTC Green Guides, Federal Food, Drug, and Cosmetic Act (FFDCA), Fair Packaging and Labeling Act (FPLA), and Proposition 65.
- 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.