nadira prashad
manager global cmc -worldwide safety and regulatory
About
Experience pharmaceutical professional, with 17 years of strong background in pharmaceutical drug development from pre-clinical to post approval . Experience in GMP manufacturing, Quality Control and Compliance, Method Validation, Tech transfers and Regulatory Affairs. Knowledge on sterile drug substance manufacture for Antibody Drug Conjugate (ADC), PAIs, Post approval changes. Authored analytical sections of Module 3 for IND and NDA filings. Cleaning validation, change controls, root cause analysis, IQ/OQ/PQ. Preparation and review CTD for IND submissions such as Module 3, and amendments, form 1572 and regulatory prerequisites for Phase 1 studies.
united states
new city
pharmaceuticals
chromatography, pharmaceutical industry, drug development, hplc, gmp, glp, method development, chemistry, laboratory, dissolution, lims, drug discovery, analytical chemistry, lc ms, v&v, biopharmaceuticals, sop, lc/ms, regulatory affairs, regulatory compliance, laboratory skills, laboratory information management system, high performance liquid chromatography
Experience
manager global cmc -worldwide safety and regulatory
pfizer
chemist
teva pharmaceuticals
Stability indicating assays for API.
chemist
gsk
Performed Dissolution Assays for Solid dosage forms, Content uniformity for Nasal inhailers.
Education
northeastern university
university of guyana
pharmacy
ramapo college of new jersey
chemistry
Cum Laude Activities and Societies: Sigma Xi
nadira prashad's Contact Information
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