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Arvin Shroff
Clarksburg, Maryland
FDA Expert
Organic Chemistry
Pharmacology
FDA [Food and Drug Administration regulatory, enforcement and compliance issues
FDA Procedures, Practices and Regulations
Review of IND, NDA, ANDA, DMF, 510(k), PMA submissions, Food Additive Petitions as well as annual, semiannual and other reports submitted to FDA
Review Standard Operating Procedures, failure investigation reports and third-party audit reports
Assist in formulating a response to FDA pertaining to FD-483, Warning Letter, Application Integrity Policy Letter, Recalls and other similar communications from the agency
Assist in drafting Corrective Action Plan, monitoring progress and accomplishment for upper management
Provide guidance and advice during acquisition of new companies or products, outsourcing manufacturing or other activities
Provide proactive enforcement guidance as well as post-enforcement recommendations (seizure, injunction and consent decree negotiations)
Training and Consultation (including Trial Judges and Court consultations) during litigation
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