Krishnakumar J Email & Phone Number

Handled more than 500 eCTD submissions.Well versed to handle eCTDXpress, Lorenz Docubridge, Knowledge Net, Extedo eCTDmanager regulatory softwares.Handled various regulatory submission including lifecycle managements. (Europe, USFDA, SFDA, CH, Qatar, Oman, Australia etc. )Known to handle Document Level Publishing using ISI Toolbox, Adobe PDF and MS.

Chennai Area, India

Exploring business opportunities for the CRO from the pharma industry and manage liaison with sponsors.Maintaining a strong network of sponsors and key contacts in the pharma industry.Attended International and national exhibitions and conferences and made favourable presentations to project and promote the services.Interacting continuously with internal.

Chennai Area, India

Handled BA/BE Studies, Phase IV trial, Phase III trial on Bone and joint infection patients, Otitis media patients and Skin infections

Thorough knowledge on ICH GCP guidelines & ICMR guidelines, Handled 60 BA/BE studies (including Post Menopausal studies and Oncologocal studies) & Phase – I & III trials. Well-versed in review of study protocol, ICF and Clinical report preparations of BA/BE studies.Achievements: Joined as a CRA and got the responsibilities like “Team Leader”, Pharmacy in.

Doctor Of Philosophy - Phd, Pharmacy

Industry Program - Clinical Trial, Research & Administration

M.Pharm, Pharmacy

B.Pharm, Pharmacy

D.Pharm, Pharmacy

International English Language Testing System