Raymond A. Bonner
- 商取引に関する訴訟及び紛争処理
- 食品・医薬品・医療機器関連の規制業務
- ホワイトカラーの弁護と捜査
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.
経験
- 代表案件
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
得意分野
- 商取引に関する訴訟及び紛争処理
- 危機管理と戦略的対応
- 食品・医薬品・医療機器関連の規制業務
- ライフサイエンス
- ホワイトカラーの弁護と捜査
- バイオテクノロジー
- Cell and Gene Therapy
- 臨床試験
- コンプライアンス カウンセリング - FDA
- コンプライアンス カウンセリング - ホワイト カラー
- 企業のリスクマネジメントと重要な問題
- Data Integrity
- 虚偽権利主張法
- 海外腐敗行為防止法/汚職禁止
- 米国食品医薬品局による執行
- Global Life Sciences Enforcement
- 医薬品適正製造基準
- 大陪審による調査
- 医療分野強制執行
- 医療訴訟
- 内部調査
- 医療機器
- 製薬
- Pre-Commercial Life Sciences Companies
- ライフサイエンス業界へのM&Aと投資におけるリスク評価と緩和
- 企業秘密と不正競争訴訟
- 公判
ニュース&インサイト
資格
弁護士資格・登録
- U.S. Court of Appeals, 4th Circuit
- U.S. District Court, District of Columbia
- U.S. District Court, District of Maryland
- District of Columbia
- Maryland
- Pennsylvania
学歴
- New York University School of Law, J.D., 1985
- University of Maryland, B.A., 1980 (summa cum laude)
クラークシップ
- Paul H. Roney, U.S. Court of Appeals, 11th Circuit (1985 - 1987)