Ramkumar G Email & Phone Number

Bengaluru, Karnataka, India

preclinical safety assessment study

Chennai, Tamil Nadu

• Quality assurance auditor for GLP preclinical toxicology (Agrochemical, Medical device, Pharma, Food additive, cosmetics etc.), Genetic toxicology, Eco-toxicology and Analytical chemistry studies• To review Study Report, Study Plan, Raw data, SOP as per GLP and ISO guidelines• Risk assessment for medical device and preparation of SOPs, protocol• To conduct audit on study and facility based to make sure GLP compliance and NABL standard• To Guide and give training on OECD and ISO guidelines, SOPs• Vendor evaluation and Verify calibration data of equipment’s

Gurgaon

worked in New Drug Discovery of Anti infective Research. Expertise in pre-clinical study of New drug by invitro and invivo(animal) screening and handling of all pathogenic microorganisms, knowledge and hands on experience in Ames mutagenicity assay.Strong interpersonal and leadership skills with broad working knowledge in quality control and assurance of pre-clinical study.Played important role and key member in in vitro microbiology studies of two clinical candidate.Worked as a study investigator during IND study of one clinical candidate (currently in phase I) and successfully completed all studies without any remarks

Gurgaon, India

Designing and conducting of all in vitro microbiological pre-clinical study of lead molecule.Key member in in vitro and in vivo microbiology study evaluation of one lead molecule.Maintenance of all microorganisms include Multidrug resistance (MDR) pathogens.Documentation and Interpretation of results.Worked in Collaborative project with GSK and Merck

Vellore Area, India

worked in community Antimicrobial Resistance’ and ‘Invasive Bacterial Infection Surveillance’ studies of H.influenzae and S.pneumoniae strains funded By INCLEN (International Clinical Epidemiology Network) and Neonatal Health Research Initiative Study funded by IndiaCLEN/USAID.Isolation, identification and confirmation of H.influenzae & S.pneumoniae strains from Study Samples like Blood, CSF, Nasal swab and other invasive body fluids.Finding antimicrobial sensitivity pattern and serotyping of isolated H.influenzae & S.pneumoniae.Co-ordination of project activities including data analysis, Preparation of progress reports and time line records.Trained personnel by conducting workshops from participating laboratories for the identification of strains, Antimicrobial Sensitivity pattern and information management

M.Sc, Microbiology, First Class

Doctor Of Philosophy (Phd), Antimicrobial Resistance

Bachelor Of Science (B.Sc.), Microbiology, General, First Class