Mettu Anvesh

Experience

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  Aizant Drug Research Solutions Pvt Ltd

  Jan 2014 - Nov 2016

  Executive in Formulation Research and development

  Prototype formulation development and finalization of formula for conducting pilot BE studies and stability studies as Per ICH Requirement.Developing and optimizing the process of different dosage forms like immediate release tablets and capsules, extended release tablets and capsules.Setting timelines for development trials and execution of pilot BE batches.Investigation of the BE results and proceeding accordingly.Preparation of different protocols for developmental studies related to formulation, process optimization studies and stability studies for different dosage forms.Involved in activities like taking of scale up batches, process optimization batches and exhibit batches of new products.Co-ordination with analytical department, regulatory department, patent department, packaging development team and development QA for development study and timely completion of project. Show less

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  Orchid Pharmaceuticals Ltd

  Dec 2016 - Jan 2018

  Research Executive

   Formulation product Development of dosage forms through ANDA approach (IR tablets, Capsules, Solution)  Technical assistance in process development, trouble shooting and resolving manufacturing related issues. Execution of Pilot, scale-up trials and Exhibit batches. Coordination with cross functional teams for successful completion and filing of dossiers to Health Authorities.

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  Aurobindo Pharma

  Jan 2018 - Apr 2020

  Asst.Manager

   Responsible for review and submission of Manufacturing and test License documents for development and manufacturing facilities to the health agency.  Responsible for review of all Product development Reports, IIG Clearance documents, Master Formulae Card, Batch Manufacturing Records, Stability Reports such as Validation reports and Transfer documents. Responsible for handling deficiencies related to formulation development and submitting clear response with in stipulated time by taking necessary laboratory trials data. Understanding of all updated guidelines required to make right dossier.  Coordination with Cross Functional Teams for the regulatory documents and query responses. Show less

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  Dr. Reddy's Laboratories

  Apr 2020 - May 2023

  Assistant Manager

   Preparation, Review and filing of ANDAs, Deficiency responses and Post approval submissions  Deficiency Response submissions to Regulatory Agency  Review of different Regulatory documents of Module 2 and 3.  Effectively manage the submissions such that they were submitted with in stipulated timelines  Impact assessment of the queries both technically and about regulatory aspects, coordination with CFT’s to clear the issues and in time escalation of the pending aspects to higher level  Understanding and interpretation/discussion of all updated guidelines within the team to make right dossier and approval of dossier in first review cycle.  Supporting to subordinates, labelling and publishing team for good quality submission.  Responsible for review of all development and analytical related documents i.e. IIG, specification clearance, Elemental impurity risk assessment report, Exhibit and intended batch documents, PDR, Method validation/ transfer reports, etc. for high-quality submission.  Responsible for preparation and submission of Controlled Correspondences to FDA.  Responsible for review and approval of change management system related to process and analytical. Show less

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  Genpact

  May 2023 - now

  • Regulatory Affairs Specialist

    May 2023 - now

  • Regulatory Affairs Specialist

    May 2023 - Aug 2024