Mudit Dixit Email & Phone Number

Bengaluru Area, India

Overall responsible for Quality and Regulatory affair of the company Overall responsible for International Regulatory affairs for drug substance, herbal extracts and Neutraceutical formulation.Overall responsible for Quality for drug substance, herbal extracts.Over all responsible for Health authorities Audits / customer audits for all the eight manufacturing units of Bayir group.Overall responsible for any certification process like DSIR, Form 3CM (Govt. of India,) Halal, Organic, Kosher, ISO, HACCP, etc.Overall responsible for all matter related to all the Government ministry like Ministry of Science and technology, Ministry of animal husbandry and agriculture, Ministry of family and health welfare etc.Overall responsible for existing and new venders audit and approval process.

India

 New Regulatory Submissions: Submission of Drug product dossier for RoW countries / Drug Master FilesGlobally. Submission of the Drug product dossier / Drug Master File for a new product in conformance with theexisting regulatory requirement. Review of data to be submitted for accuracy and consistency with the regulatoryrequirements. Life Cycle Management: Documenting and reporting the changes with respect to the Drug product dossier/Drug Master File submitted with the different health authorities Handling Deficiencies: Proactive and scientific approach towards the regulatory deficiencies received andsubmission of quality response within the stipulated time thereby avoiding repeated deficiency, facilitating insecuring approval for the Drug Product in time.

Bengaluru Area, India

 New Regulatory Submissions: Submission of Drug product dossier for RoW countries / Drug Master FilesGlobally. Submission of the Drug product dossier / Drug Master File for a new product in conformance with theexisting regulatory requirement. Review of data to be submitted for accuracy and consistency with the regulatoryrequirements. Life Cycle Management: Documenting and reporting the changes with respect to the Drug product dossier/Drug Master File submitted with the different health authorities Handling Deficiencies: Proactive and scientific approach towards the regulatory deficiencies received andsubmission of quality response within the stipulated time thereby avoiding repeated deficiency, facilitating insecuring approval for the Drug Product in time.

Bengaluru Area, India

 New Regulatory Submissions: Submission of Drug product dossier for RoW countries / Drug Master FilesGlobally. Submission of the Drug product dossier / Drug Master File for a new product in conformance with theexisting regulatory requirement. Review of data to be submitted for accuracy and consistency with the regulatoryrequirements. Life Cycle Management: Documenting and reporting the changes with respect to the Drug product dossier/Drug Master File submitted with the different health authorities Handling Deficiencies: Proactive and scientific approach towards the regulatory deficiencies received andsubmission of quality response within the stipulated time thereby avoiding repeated deficiency, facilitating insecuring approval for the Drug Product in time.

Bengaluru Area, India

 New Regulatory Submissions: Submission of Drug product dossier for RoW countries / Drug Master FilesGlobally. Submission of the Drug product dossier / Drug Master File for a new product in conformance with theexisting regulatory requirement. Review of data to be submitted for accuracy and consistency with the regulatoryrequirements. Life Cycle Management: Documenting and reporting the changes with respect to the Drug product dossier/Drug Master File submitted with the different health authorities Handling Deficiencies: Proactive and scientific approach towards the regulatory deficiencies received andsubmission of quality response within the stipulated time thereby avoiding repeated deficiency, facilitating insecuring approval for the Drug Product in time.

India

Bangalore

 New Regulatory Submissions: Submission of Drug Master FilesGlobally. Submission of the Drug product dossier / Drug Master File for a new product in conformance with theexisting regulatory requirement. Review of data to be submitted for accuracy and consistency with the regulatoryrequirements. Life Cycle Management: Documenting and reporting the changes with respect to the Drug product dossier/Drug Master File submitted with the different health authorities Handling Deficiencies: Proactive and scientific approach towards the regulatory deficiencies received andsubmission of quality response within the stipulated time thereby avoiding repeated deficiency, facilitating insecuring approval for the Drug Product in time.

Ph.D, Pharmaceutics

Activities and Societies: Research

M.Pharm, Industrial Pharmacy

B.Pharm, Phamacy