Purvin Shah

Experience

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  Lambda Therapeutic Research

  Nov 2010 - Oct 2012

  CRA

  Preparation protocol,ICF,CRF.BE NOC & T-license application as applicable,IEC approval ,protocol training of study personnel involved,ICF presentation, logistic handling & conduction of clinical phase of the study, online and retrospective QC of the documents for completeness and correctness, preparation of clinical update at the end of the study and intimation to the IEC & review of final report, archival of the project, resolution of the sponsor concerns etc.In addition to this my role also involves periodic review and updation of SOP's and assistance in resolution of regulatory concerns. Show less

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  Sun Pharmaceutical Industries Ltd

  Oct 2012 - Apr 2014

  CRA-1

  To provide scientific inputs in study designs for novel dosage forms like injection, emulsion, orally disintegrating tablets, orally dispersible delayed release tablets etc for NDA as well as ANDA submissions. Preparation of draft Protocol, ICF, IB, CRF based on literature information for the purpose of DCGI approval /BE NOC application as applicable. Pharmacokinetic data analysis, Pharmacokinetic report review etc. Sample size justification Analysis of the Time versus Concentration data using WinNonlin Professional software to calculate Pharmacokinetic parameter. Show less

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  Gowrie Healthcare Private Ltd.

  Oct 2014 - Nov 2015

  Regulatory Affairs Executive

  Experience in filling different type of regulatory applications like MRP, DCP, National application etc. Literature search and module compilation for the filling of the bibliographic application, generic and hybrid submission. Application for the biowaiver justification, line extension application and justification for bridging the BE study for different formulations during development stage and final formulation To provide scientific inputs regarding the overall conduct of the BE study which includes selection of the reference product, fulfilling different regulatory requirements of the BE study, selection of CRO for the conduct of the study, Protocol review and finalization, monitoring of the BE study, report review, PK data review and compilation in the dossier for the submission to the regulatory agency. Handling the deficiency reports from the regulatory agency and satisfactorily responding them in stipulated timeline. Show less

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  Veeda Clinical Research

  Nov 2015 - Feb 2023

  Project Manager

  Current profile includes overall project management of BE study in timely manner in compliance with regulatory requirement, fulfilling sponsor requirements, study feedback in terms of BE study evaluation report

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  Labcorp Drug Development

  Feb 2023 - Jan 2024

  Pharmacokineticist
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  TechObserver (FSP TO Abbott)

  Jan 2024 - now

  Manager clinical Pharmacology and Pharmacokinetics