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Best Industrial Training Program in Regulatory Affairs by GIRA in Pune

<br>Global institute of Regulatory Affairs Provide Full Time Courses/Part Time Courses/Distance Learning in Biotech & Food Regulatory, QA/Qc Program,ECTD Training.

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Best Industrial Training Program in Regulatory Affairs by GIRA in Pune

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  1. An ISO 9001:2008 Certified Institute Dear Student, We wish to inform that Global Institute of Regulatory Affairs (GIRA) is a Group Company of Perfect Pharmaceuticals Consult- ants Pvt Ltd (PPCPL) reputed RA consulting firm in INDIA lo- cated at Pune. GIRA introduces a distance learning program in the field of Regulatory Affairs. #Program Name – PG Diploma in Regulatory Affairs “GIRA is an ISO 9001:2008 Certified Institute” “Accredited by Joint Accreditation System of Australia & New Zealand (JAS-ANZ)” OTHER COURSES BY GIRA: eCTD Submission QA & QC Pharma Validation Medical Devices Biopharmaceuticals Food/ Food Products Pharmacovigilance GMP In Pharma Industry ADDRESS: Prestige Classic Building, D-Wing, Office No G4 & G5, Dawa bazaar, Behind Mayur Trade Center, Pune- Mum Highway, Chinchwad Station, Pune – 411019 #LEARNING OUTCOME: Understand Regulatory Concepts Able to write and review Regulatory Documents Marketing Authorization from different countries Preparation for audits and inspections Become an RA professional #TOPICS COVERED: Intro to RA: US FDA, UK MHRA, EDQM, EMEA Regulatory Bodies: DCGI, CDSCO, MHLW Regulatory Guidelines: ICH & WHO Guidelines CTD & ACTD Submissions (API & Formulation) US Dossier Submissions: US DMF, NDA, ANDA EU Dossier Submissions: EU DMF, ASMF, CEP/ COS Introduction to eCTD Submissions Module 4 & 5: Non-Clinical and Clinical Documents PSUR’s Annual Updates & Renewals FOR DETAILED INFORMATION: Call us at: 9595 750 750 / 020 46704472 Mail us at: info@regulatoryinstitute.com Explore More: www.regulatoryinstitute.com

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