ARIF NOORANI helps life sciences companies navigate U.S. Food and Drug Administration (FDA) compliance requirements in the United States and around the world covering multiple product portfolios (pharmaceuticals, medical devices, biologics and vaccines, and combination products). He guides clients through a range of matters related to good manufacturing practices (cGMP/QSR), clinical trials, data integrity investigations, pharmacovigilance, good distribution and storage practices, and product quality and safety reporting obligations. Arif prepares his clients for FDA inspections to identify risks early and builds business minded corrective and preventive action plans to achieve sustainable compliance. Arif frequently leads internal reviews to assess whistleblower complaints and potential compliance violations, and defends companies during FDA and U.S. Department of Justice (DOJ) investigations and enforcement actions. He provides strategic counseling that helps resolve inspection observations, warning letters, import alerts, and consent decrees. Arif also counsels clients engaged in corporate life sciences transactions, including negotiating representations and warranties for FDA-related diligence.
合伙人律师
Arif S. Noorani
- 食品、药品及医疗器械监管
经验
- 代理事宜
Arif’s experience has included, for example:
- Counseling dozens of pharmaceutical, biologics, and medical device manufacturers located across the world that are preparing for FDA inspections or responding to FDA requests for information, 483 observations and warning letters.
- Representing a global drug manufacturer in a criminal and civil data integrity investigation involving alleged adulterated products (resulting in the DOJ declining to prosecute).
- Performing gap assessments and providing compliance counseling to drug and device manufacturers on designing, implementing, and governing compliance action plans across a range of quality systems, including aseptic practices, good documentation practices, corrective and preventive actions, supplier management, complaint handling, and adverse event safety reporting.
- Counseling a biopharmaceutical company in a criminal and civil investigation involving alleged off-label promotion and kickbacks (resulting in the DOJ declining to prosecute).
- Representing a pharmaceutical company in a civil and criminal investigation involving alleged manufacturing and reporting violations and false statements (resulting in the DOJ declining to prosecute).
- Leading numerous internal investigations concerning alleged cGMP/QSR compliance violations at manufacturing facilities based in the United States, Europe, Asia, and Australia.
- Providing regulatory due diligence advice for a variety of life sciences transactions (e.g., represented IDEX Corporation (NYSE: IDEX) in its US$1 billion acquisition of Mott Corporation and its subsidiaries).
- Successfully defending a biopharmaceutical company in FCA qui tam litigation involving alleged off-label promotion and kickbacks.
- Serving as the day-to-day counsel for a major distribution company regarding compliance with the Drug Supply Chain Security Act (DSCSA), including suspect and illegitimate product and regulatory reporting obligations.
- Serving as the day-to-day counsel for a multinational pharmaceutical company managing requirements for a GMP-based consent decree.
Related Resources
BLOGS
相关业务能力
服务
新闻与观点
证书
执业资格及证书
- 美国华府哥伦比亚特区
- 美国乔治亚州
学历和教育
- Washington and Lee University School of Law, 法学博士, 2009 (magna cum laude, Order of the Coif, A.H. McLeod-Ross Malone Award)
- The University of Chicago, 文学学士, 2006 (with honors)
书记员
- Henry C. Morgan Jr, U.S. District Court, E.D. of Virginia (2010 - 2011)