Named to the Washington DC Rising Stars list in the area of Food and Drugs (from 2018 to 2020), Delia Deschaine focuses her practice on advising pharmaceutical and biotechnology clients on a broad range of FDA regulatory matters. Her services include:
- Providing advice on pharmaceutical and biotechnology development and approval
- Advising on pharmacovigilance, current Good Manufacturing Practices (“cGMPs”) compliance, Risk Evaluation and Mitigation Strategies (or “REMS”), registration and listing, field alert reporting, import and export controls, recalls, labeling, advertising and promotion, and Drug Supply Chain Security Act compliance
- Conducting internal investigations, and defending clients in government investigations and litigation
- Representing manufacturers and their suppliers in responding to FDA Form 483s, Warning Letters, and Import Alerts
- Drafting and negotiating commercial agreements and conducting diligence in corporate transactions
Delia has a deep understanding of FDA requirements related to cGMP and FDA Quality System Regulations (“QSR”). She routinely counsels client on their obligations related to cGMP and QSR, including quality systems, data integrity, supply chain management, aseptic processing, validation, and sterilization.
In addition, Delia focuses her practice on the federal and state regulation of controlled substances. She defends clients, including pharmaceutical and biotechnology companies, distributors, pharmacies, hospitals, physician groups, academic medical centers, and other researchers, in government investigations and litigation, and advises them on:
- Controlled substances scheduling matters
- Compliance with U.S. Drug Enforcement Administration (“DEA”) and state law regulatory requirements
- Conducting internal investigations
Delia also counsels clients on cannabis law matters. She was named to the Washington DC Rising Stars list in the area of Cannabis Law in 2020, and has advised pharmaceutical, researcher, conventional food, dietary supplement, and cosmetic companies on FDA, DEA, U.S. Department of Agriculture, and states’ regulation of cannabis (including hemp), cannabis-derived products, and synthetic cannabinoids.
Prior to joining the firm, Delia served for six years as an attorney for an international law firm in the areas of pharmaceutical and biotechnology law, and two years at a boutique FDA law firm , both in Washington, DC. Before then, she was an Attorney Advisor for the DEA through the Attorney General’s Honors Program, where she received a Performance Award in 2011. She was also a legal intern for Magistrate Judge Susan K. Gauvey of the U.S. District Court for the District of Maryland.