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Akshay Kakde

Akshay Kakde

QA Officer

Followers of Akshay Kakde3000 followers
location of Akshay KakdePune, Maharashtra, India

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  • Timeline

  • About me

    CMC, Post Approval Changes (PAC), RCGM, CTA, MAA. CDSCO, Biologicals, Vaccines & rDNA products, Clinical Trials, Dossier CTD, ACTD, NSWS, Regulatory Science, Drug Regulatory Affairs, Biosimilar.

  • Education

    • Dr. D.Y.Patil Institute of Pharmaceutical Sciences and Rsearch, Pimpri,Pune 411018

      2016 - 2018
      M.Pharmcy Quality Assurance Techniques A+

    • Kulbhushan Highersecondary College, Aurangabad

      2010 - 2012
      High School Diploma

    • Deulgoan raja high school deulgoan raja

      2008 - 2010
      Secondary education

    • Dusrbid, Deulgaon raja

      2005 - 2010
      Primary eduction

    • Anuradha College of Pharmacy, Chikhali.

      2012 - 2016
      Bachelor of Pharmacy - BPharm Medicine A

  • Experience

    • Milan Laboratories (India) Pvt. Ltd.

      Jun 2018 - May 2019
      QA Officer

      Worked as QA officerPreparation of BMR and BPR.IPQA activity in production and Packaging area.Handling of change control and deviations.Preparation of SOPs. Handling of Audits and queries from customers.Internal audits.

    • Gennova Biopharmaceuticals

      Jun 2019 - Mar 2023

      Experience in mRNA vaccine for COVID-19.Submission of CT 10, Form 29, CT 04 (Phase I, II and III), Stock Piling and Emergency Use Authorization.Vaccine for Omicron COVID -19 Submission CT 10, CT 04 application.FDA and DCGI activities, Dossier filing for ASIAN Region in ACTD format. Worked as RA officerPreparation of application for FDA and DCGI submissions for rDNA products.Preparation of application for various marketing certificates for rDNA products.Dossier preparation and submission to ASIAN Region and query response to the authorities.Test licence application in Form CT 10 and Form 29.Query response to licenceing authority.

      • Regulatory Affairs Executive

        Jun 2019 - Mar 2023

      • Regulatory Affairs Officer

        Jun 2019 - Jul 2022

    • Intas Pharmaceuticals

      Mar 2023 - May 2023
      Senior Executive

      Domestic submission, CT applications, Important NOC, Test Licences for Biological products, rDNA origin.Preparation of query responses to the authorities.

    • M.J. Biopharm Private Limited

      Jun 2023 - now
      Senior Executive

      M.J. Biopharm Private Limited, Hinjawadi Phase II, Pune base growing organisation in Biopharm division.where I am playing a role in Regulatory Affairs as senior executive.Handling of domestic market and need of market.Submission to Indian regulatory Authority.Hand on SUGAM PORTAL.FDA and DCGI support, application and approval.Sound knowledge of NDCT 2019.5+ yr experience in biological product and it's submission.

  • Licenses & Certifications

    • Drug Regulatory Affairs

      Skillon School of Professional Excellance

  • Honors & Awards

    • Awarded to Akshay Kakde
      Spot Award Mr. Sachin Gundecha Mar 2022 Submission of Clinical Trial Applications For COVID -19 in Form CT 04
    • Awarded to Akshay Kakde
      Value Champion Mr. Sachin Gundecha Feb 2022 Exceptional work done for clinical trial applications in Form CT 04 at SUGAM PORTAL and CT 11 NOCs
    • Awarded to Akshay Kakde
      IASTAM - Baidyanath Award for Best Technological Adaptation for the Ayu.Classical Product Concept. IASTAM - Baidyanath February 1, 2019 IASTAM - Baidyanath Award for Best Technological Adaptation for the Ayu.Classical Product Concept. The award comprises of Certificate of Merit and Cash prize of 51000/-P.G.student Mr.Akshay Kakde for support extended during the project work.
    • Awarded to Akshay Kakde
      Smily Card Mr. Deepkar Gerange ( Production Manager) October 1, 2018 This smiley card recived for prepartion of document within time with high accuracy.

  • Volunteer Experience

    • Student Representative

      Issued by Dr D Y Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune -18. on Jun 2017
      Dr D Y Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune -18.Associated with Akshay Kakde