Elise N. Paeffgen

Pharmaceutical, Controlled Substance, and Medical Device Manufacturing, Distribution, and Disposal

• Counseling pharmaceutical manufacturers, logistics providers, and forward and reverse distributors on pharmaceutical waste characterization, management, transportation, and disposal; DEA Disposal Act compliance; and federal and state licensure matters.
• Counseling drug manufacturers and distributors on compliance with complex, nuanced, and variable state laws in 50 states dictating drug licensing and registration, sale and distribution, and related ownership issues.
• Advised a distributor on controlled substance storage and security issues.
• Advising health care facilities on pharmaceutical and medical/infectious waste management.
• Providing strategic advice to drug manufacturers on compliance with pharmaceutical take-back ordinances.
• Conducting environmental and FDA regulatory due diligence reviews of drug, medical device, and biologics companies, hospitals, and pharmaceutical reverse distributors and advising clients on the regulatory risk profiles of companies subject to pending acquisitions and mergers.
• Reviewing environmental-related statements in securities filings and investor materials for drug and medical device companies.
• Spent more than 100 days inside pharmaceutical manufacturing facilities in the U.S. and Europe managing FDA inspections, responding to Form FDA 483s and warning letters, and implementing significant remedial actions.
• Preparing domestic and international manufacturers for FDA inspections.
• Advising on communication strategies and developing summaries for foreign authorities regarding Form FDA 483 and warning letter responses.
• Advised a pharmaceutical company on current good manufacturing practices for sterile drug products and strategy for responding to Form FDA 483 observations and warning letter concerns regarding environmental monitoring, microbiological testing, aseptic processing, and sterility assurance.
• Assisted a foreign API manufacturer in lifting two import alerts and a warning letter close-out.
• Advised a pharmaceutical manufacturer on remediation during an FDA criminal investigation.
• Counseled a domestic drug manufacturer on warning letter response strategies relating to complaint investigations and trending, field alert reports (FAR), and corrective and preventive action (CAPA) effectiveness.
• Provided regulatory counsel and support for remediation efforts across multiple sites and facilities of a foreign manufacturer of APIs, intermediates, and finished drug products.
• Advising on the regulation of antimicrobial pesticides (sterilants and disinfectants) for use on medical devices.

Elise Paeffgen’s practice is centered at the intersection of EPA, FDA, and DEA regulation. Elise works with manufacturers, importers, and forward and reverse distributors to effectively navigate EPA, FDA, and DEA regulations and minimize enforcement risks. She provides counsel to FDA-regulated clients, such as pharmaceutical, medical device, cosmetic, and food manufacturers, on issues ranging from current good manufacturing practices (CGMP) to the management of hazardous waste pharmaceuticals. On environmental compliance and enforcement matters, Elise represents health care facilities and domestic and international companies in the consumer product, chemical, pesticide (antimicrobial), automotive, construction equipment, and oil and gas industries.

In addition to a J.D., magna cum laude, from Vermont Law School, Elise earned a master of environmental management from Yale University School of Forestry and Environmental Studies, with concentrations in climate change and corporate environmental management. During her joint degree program, Elise worked for the U.S. EPA Office of Enforcement and Compliance Assurance. Elise received a B.A. in environmental studies and politics from Oberlin College, and was awarded high honors. 

Elise has been named a Super Lawyers “Rising Star” each year since 2014.

Bar Admissions

• District of Columbia
• Ohio

Education

• Vermont Law School (J.D., 2009)
• Yale University (M.E.M., 2009)
• Oberlin College (B.A., 2004)

Memberships