Arif S. Noorani

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.