Madan Chilakuri
Staff Pharmacist at Wheaton Franciscan Healthcare
Based in Chicago, United States
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Seniority
Staff
Department
Healthcare & Human Services
Location
Chicago
Industry
Hospitals and Health Care
Company size
10001+
Contact information
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m•••••••@healthcare.ascension.org
Phone
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Background
About Madan Chilakuri
Regulatory Affairs Consultant with extensive experience in interacting with the USFDA in preparing and submitting Abbreviated New Drug Applications (ANDAs), Pre-IND Meeting Requests and Briefing Documents, Controlled Correspondence Letters, Freedom of Information Requests, General Questions etc Drug Master Files (DMFs), Drug Establishment Registrations. Expertise in eCTD compilation and publishing of ANDA/NDA submissions, DMFs, Pre-IND Meeting Requests, Life-cycle Management activities. Participated in pre-IND meetings and negotiated successfully for a waiver of clinical studies in support of NDA filings of injectables, liquid orals through 505(b)(2) regulatory pathway
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