Prasanna Krishna Patil

I aspire to build a career with a leading corporate in a high-tech environment, focusing on regulatory and project management, alongside committed and dedicated professionals. This will enable me to fully explore and realize my potential. I am eager to contribute as a key player in a challenging and creative setting.

• Diploma in hands on HPLC
• Course on Computer Concepts
• Elementary Drawing Exam

• To carry out feasibility activity for new request from client and prepare a quotation.
• Communication with clients for query related to feasibility, technical aspects and study planning.
• Co-ordinating with directors, clinical, bio-analytical, statistical, QA dept. for initiation of study to dispatch of final report.
• Keep update to clients for progress of studies.
• To identify and evaluate project risk and take corrective actions as per the requirements in co-ordination with department head/designee and management.
• Collaborate with cross functional teams to draft projects scheduled and looking after administrative part for all studies, Monitoring timescale and resources used to achieve project timeline.
• Responsible for preparation and review of DCGI Application of BENOC and Test Licence, for export purpose as well as Bioequivalence study on SUGAM portal.
• Responsible for Query reply and to all DCGI related like BENOC, Import permit, and Working Standard import license as well as Amendment and Notification.
• Responsible for preparation and submission of DCGI Notification for IEC documents submission.
• Responsible for protocol amendment application for Bioequivalence study on SUGAM portal/Mail communication with Central/Zonal CDSCO office.
• Responsible for daily follow up from SUGAM portal and further status update to President Regulatory Affairs.
• Preparation and Review of BENOC and Test License application required document in communication with study sponsor.
• Preparation and Review of DCGI (CDSCO) application for facility/Site approval.
• Responsible for communication with CBN NCB and Local FDA for Quarterly return Narcotic Drugs & Psychotropic Substances as well as approval and licenses, import permits.
• Responsible for addition and renewal of Pharmacy Licenses as well as Directors & pharmacists associated with it. & follow up the activities.

Date of Birth: 01/11/97

• Marathi
• English
• Hindi

• Writing
• Photography
• Reading
• Drawing
• Exploring