Raymond A. Bonner
- 商业诉讼及争议
- 食品、药品及医疗器械监管
- 白领犯罪辩护及调查
Mr. Bonner is consistently ranked among the nation’s top healthcare: pharmaceutical/medical products regulatory lawyers by Chambers USA, Who’s Who Legal and LMG Life Sciences where he is recognized as a “Life Sciences Star.” Clients are regularly impressed by Mr. Bonner who handles safety, compliance and efficacy issues. They have said “he is a former federal prosecutor and works with the district officers, the inspectors. He knows them all and has credibility with the district offices… we have had some really sensitive quality matters and I needed someone I really trusted. He has been fabulous.” In Chambers USA clients praise him as “one of the best good manufacturing practice and product quality lawyers around.” In Who’s Who Legal Mr. Bonner’s “wide and detailed knowledge” of the area complements his “user-friendly approach.” Within the field, he is very well known for the quality of his representation of clients in relation to government investigations, enforcement proceedings and other related litigation.
Prior to joining Sidley, Mr. Bonner served as an Assistant United States Attorney in the District of Maryland for six years, where he prosecuted pharmaceutical application and GMP cases and litigated other FDA-related cases. Throughout his tenure as a prosecutor, he counseled FDA and its Special Prosecution Staff investigating the healthcare industry. Mr. Bonner is the recipient of the FDA’s Harvey W. Wiley Medical and Commissioner’s special citation.
经验
- 代理事宜
Mr. Bonner’s experience includes:
- Regularly visiting manufacturing sites throughout the world to provide regulatory and compliance support regarding GMP and QSR matters
- Representing companies in connection with Foreign Corrupt Practices Act investigations and compliance programs, trade secret issues, and commercial matters
- Assisting clients with complex non-conforming product, corrective and preventive action (CAPA), data integrity and product impact investigations
相关业务能力
- 商业诉讼及争议
- 危机管理与战略应对
- 食品、药品及医疗器械监管
- 全球生命科学
- 白领犯罪辩护及调查
- 生物科技
- Cell and Gene Therapy
- 临床实验
- 合规咨询-食品药物管理局
- 商业罪案合规咨询
- 企业风险管理及关键事项
- Data Integrity
- 虚假申报法案
- 美国《海外反腐败法》/反贿赂
- 食品药物管理局执行事宜
- Global Life Sciences Enforcement
- GMP认证 (良好作业规范)
- 大陪审团调查
- 卫生保健执行
- 卫生保健诉讼
- 内部调查
- 医疗器械
- 医药
- Pre-Commercial Life Sciences Companies
- 生命科学业务投资及并购风险评估和防范
- 贸易秘密与不正当竞争诉讼
- 出庭辩护
新闻与观点
证书
执业资格及证书
- 美国第四巡回上诉法院
- U.S. District Court, District of Columbia
- U.S. District Court, District of Maryland
- 美国华府哥伦比亚特区
- 美国马里兰州
- 美国宾夕法尼亚州
学历和教育
- 美国纽约大学法学院, 法学博士, 1985
- University of Maryland, 文学学士, 1980 (summa cum laude)
书记员
- Paul H. Roney, U.S. Court of Appeals, 11th Circuit (1985 - 1987)