Jay Samudralwar Email & Phone Number

Jay Samudralwar Skills

• Regulatory, CMC & Conformance
• Pharmaceutical Industry
• Pharamceutical & Biotech products NDA, ANDA, DMF, IND, IMPD, GDUFA
• MAAs
• CTD
• eCTD
• Preparation of supplements / Variations in eCTD format
• Pharm & Biotech product regulations in US, EU, AP/LA, Middle east, Japan
• Injectable, lyophilized, frozen, solid and liquid drug products
• LIMS
• Stability studies
• Validation
• Bioanalytical techniques
• Analytical methods validation
• Process Validation
• Technical reports
• Biotechnology
• Drug Development
• Project management
• Supevisiory skills
• Team player
• Proficient in multiple languages
• FDA
• GMP
• SOP
• Technology Transfer
• Data Validation
• CMC
• Excipients
• Art
• Test Procedures
• Therapeutic Areas
• Regulatory
• RMS
• Pharamceutical and Biotech Products Nda
• Pesticide
• Supervisor
• ELISA
• Quality Control
• Supplements
• Gdufa
• Pharm and Biotech Product Regulations in Us
• Infectious Diseases
• Inspection
• Laboratory
• Lyophilized
• Regulatory Agencies
• Databases
• Transplant
• Organ
• Supply
• Revisions
• Pharamceutical
• Specifications
• Staff Training
• Solid and Liquid Drug Products
• Regulations
• Documentum
• HPLC
• Impd
• NDA
• Sales
• Communication
• Supervision
• Cmc and Conformance
• Reviews
• Ap/La
• Fast Track
• Filing
• OPs
• Validation Reports
• Middle East
• Strategy
• QC
• Timelines
• APIs
• Row
• Product Testing
• Dmf
• Fluids
• Maintenance
• Variations in Ectd Format
• Change Control
• Vaccines
• Management
• Bone
• IND
• Pharm and Biotech Product
• Operations
• DBMS
• Preparation of Supplements
• Annual Reports
• Oncology
• Proficient in Multiple
• C
• Analytical Methods
• Regulatory Requirements
• Matrices
• ANDA
• Trackwise
• Template
• Nds
• Molecular Biology
• Regulatory Filings
• Phase Ii
• CEP
• Japan
• Registration
• Testing
• Intermediates
• UV
• PDM
• Injectable
• Schedules
• Protocol
• Frozen
• Ep
• Tissue
• Raw Materials
• IR
• Ion Chromatography
• USP