Sandesh Krishna Katar Email & Phone Number

Overall experience of >10 years with different CROs and service providers. Actively working on authoring Clinical Evaluation Report (CER) for Class I to Class III devices in accordance with MEDDEV 2.7.1 Rev 4, EU MDR 2017/745 guidelines along with IMDRF SG5 document. .In the past, I have been developing, preparing and reviewing documents like Synopsis, Protocols, Informed Consent Forms, Case Report Forms and Clinical Study report, CTD modules 2.4, 2.5, 2.6 and 2.7, DBE Tables, CSBE, BTIF and additional documents required for dossier submission of Phase I, IV, BA/BE and patient based PK study. End to end knowledge, experience in bioavailability and bioequivalence studies across various regulatory requirements. I excel in writing responses for both sponsor and regulatory queries.Proved productive, successful as an independent performer and as well as a team performer. My key strengths are analytical thinking, problem solving ability, being proactive and leadership. My highest priority is ensuring a quality delivery on time.

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  Jawaharlal Nehru Technological University

  Pharmacy