Ankit Mehta Email & Phone Number

Maharashtra, India

Prepare and manage regulatory registration filings across product lifecycles for India market.Responsible for compiling, reviewing and filing of dossiers for the clinical trial studies. Reviewing and maintaining regulatory database for registration certificates, import licenses, post marketing commitment, package insert submission so as to facilitate timely submission of the applications as well as maintaining regulatory compliance at the highest level.Developing and maintaining knowledge of local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards.Manage end-to-end local product packaging and labelling from a regulatory perspective.Collaborate with the global teams in creating regulatory strategies for submission during early stages of product development.Working in close collaboration with the tender management team and third party vendor for the procurement of certificates from the state FDA in a timely manner for tender purposes.

India

Preparation of dossiers for biological, vaccines and medicinal products registration for India market.Performing dossier submissions: Marketing Authorization, Fresh Registration applications, within scheduled timelineManage and execute life cycle management compliance activities: renewal dossiers and post approval variations submissions, preparation of response against query response raised by regulatory agencies and getting approvals in a timely manner.Ensure regulatory compliance, accuracy with respect to the submission of labelling updates to the Health Authority and subsequently getting approvals.Work closely with artwork management team to facilitate labelling implementation Monitoring and Maintenance of Regulatory database Management system (Vault RT)

India

Prepared and managed regulatory submission dossiers for registrations, renewals, new drug applications and variations of active pharmaceutical ingredients (APIs) for India market.Involved actively in updation and monitoring of regulatory events in databases (SHARE)Participated in the preparation of planning of Regulatory maintenance activities (Eg. Renewal submissions) and monthly reports.Performed regulatory submissions through health authority portal (SUGAM)Organized and managed test licenses, export NOCs, NOC for Form 29 applications for finished products and APIs through zonal state authority office.

Investigation of drug permeability through intestinal mucus and the investigation of colonic mucus in hindering drug absorption.Ran diffusion cell system technique to determine drug diffusion through mucus.Performed reverse phase HPLC & spectrophotometry analysis to measure the absorbance rate of different drugs in order to determine its permeability through intestinal mucus & membrane respectively. Designed & developed standard procedures for the experiment.Documented requirements in early stages of the experiment.

Conducted an in-depth investigation on Reactive Distillation Process and its industrial applications.Developed a heterogeneously catalyzed reactive distillation process for the production of n-butylacetate by the esterification of n-butanol with acetic acid.Analyzed Thermodynamic aspects & Reaction Kinetics of n-butyl acetate synthesis.Managed simulation studies that can serve as the basis for the scale-up of the process and further optimization with respect to economic issues.

Ms Thesis, Pharmaceutical Sciences

Ms, Pharmaceutical Sciences

Bachelor Of Engineering, Chemical Engineering