Niraj Patel Email & Phone Number

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat, India

 Responsible for review and development of systems. Guiding for Method development and Method validation of Bio analytical methods in a perfectly maintained GLP environment by UPLC & LC/MS/MS. To respond the Deficiency letters of Regulatory Agency. To plan project activities for analytical operations.  To authorize the project in charge and the personnel involved in the study. To coordinate with the principal investigator in writing study protocols. To review and approve the study protocol. To review and approve method validation protocol and validation report. To take corrective action for any unforeseen event that can affect the quality and integrity of study. To review and verify deviations, if any, to the approved study protocol and approved SOP during the conduct of the study. To coordinate with the quality assurance unit for audit of the study data and ensure that all the corrective actions of QAU findings are incorporated and documented. Keep track of the delivery of reports. Execution and maintenance of quality systems.

Ahmedabad Area, India

 Accomplished and cleared regulatory audits conducting EMEA, USFDA (twice), WHO, Thailand FDA, NPRA (Malaysia) and DCGI for clinical facility maintained within CRO-Cadila pharmaceuticals Ltd. Leading the clinical investigation and performing root cause analysis with respect to non- conformance observed during the clinical site inspection. Assists with the creation of quality/compliance training programs with respect to training matrix. Ability to independently review clinical research protocols(Bioequivalence, Phase-I to III) ,Case report forms, trial master file, Study site files and performing vendor audit for outsourced activities for example evaluating emergency hospital services, contractual laboratory services. Site audits for vaccine (phase-I to III) and pharmacodynamics trials. Coordinating with regulatory for the Information Request, complete response received in lieu of ANDA dossier submission.  Auditing the in life process audit like pre-dosing , administration of IP to the subjects ,post dose blood collection ,Recording and Reporting methods of AEs , SAE’s to the Regulatory EC and Sponsor.  Ethical considerations as per ICH-GCP guideline with respect to subject’s recruitment. Leading the team of ANDA submission from CRO to regulatory area for assisting in readiness for eCTD submissions from 2016 till date.  Review the corrective action plans (CAPAs) provided to the findings observed for verifying compliances for adequacy. Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed in reports. Identify and track the project team compliance to SOPs for submission and approval of the audit reports through communication with the project managers.

Ahmedabad Area, India

 Primary responsibilities include leading the bioanalytical group of 3 scientists at Synchron in support of Method development, method validation and biostudies. Development and validation of new bioanalytical procedures for monitoring drugs and metabolites in the biological fluids using LC-MS/MS as per USFDA & BRAZILIAN guidelines. Responsible for Calibration and maintenance of LC-MS/MS Waters Quattro Premier XE and Acquity UPLC Processing of study samples of various BA/BE projects under the norms of GLP using instrument like LC-MS/MS.

M.Sc, Organic Chemistry

Bachelor Of Science (B.Sc.), Chemistry