Biochemistry & Pharmacology: Open Access
Open Access
ISSN: 2167-0501
ISSN: 2167-0501
Krishnasarma Pathy
Department of Synthetic Chemistry, IPL research centre
Lucknow, India
I am KRISHNA SARMA PATHY completed PhD in synthetic chemistry , 20 years pharmaceutical product development in R&D experience. 12+ years drug master file submissions according to regulatory chemistry, manufacturing and controls (CMC) experience at CDER/FDA on generic drugs API ‘S and small molecular-weight drugs, peptide drugs and protein drugs . 6+ years research experience analytical method development and quality control as per requirements CBER/FDA. 4+ years experience as regulatory CMC for drugs (small synthetic, peptide, protein, combination products) knowledge in regulatory guidance and strategy from pre-IND through NDA/BLAapproval
Small synthetic, peptide, protein, combination products