An ISO 9001:2008 Certified Institute

Dear Student,
“GIRA is an ISO 9001:2008
Certified Institute”
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

#LEARNING OUTCOME:
“Accredited by
Joint Accreditation System
of Australia & New Zealand
Understand Regulatory Concepts
(JAS-ANZ)” Able to write and review Regulatory Documents
Marketing Authorization from different countries
OTHER COURSES BY GIRA:
Preparation for audits and inspections
eCTD Submission Become an RA professional
QA & QC
Pharma Validation #TOPICS COVERED:
Medical Devices
Biopharmaceuticals
Food/ Food Products Intro to RA: US FDA, UK MHRA, EDQM, EMEA
Pharmacovigilance Regulatory Bodies: DCGI, CDSCO, MHLW
GMP In Pharma Industry 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
ADDRESS:
Introduction to eCTD Submissions
Module 4 & 5: Non-Clinical and Clinical Documents
Prestige Classic Building, PSUR’s Annual Updates & Renewals
D-Wing, Office No G4 & G5,
Dawa bazaar, Behind Mayur
Trade Center, Pune- Mum FOR DETAILED INFORMATION:
Highway, Chinchwad Station,
Pune – 411019
Call us at: 9595 750 750 / 020 46704472

Mail us at: info@regulatoryinstitute.com

Explore More: www.regulatoryinstitute.com