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Courses IN INR IN USD
Advanced course in GLOBAL REGULATORY AFFAIRS [GRA-API, Formulations, Medical Devices, Biosimilars, OTC]
REGULATORY AFFAIRS[Formulation]
REGULATORY AFFAIRS[API]
QA-QM [ Quality Assurance and Quality Management]
Regulatory Submissions as per CTD-eCTD, ACTD , NeeS
Advanced course in Clinical Research[CR]
Advanced course in Pharmaceutical Documentation [PD]
Advanced course in Pharmacovigilance [PV]
Advanced course in Patents Laws and Procedures [IPR]
Advanced course in Pharmaceutical Management[PM]
Advanced course in Medical Writing [MW]
Advanced course in NUTRACEUTICALS[NUTRA]
GLOBAL Medical Devices Regulations i.e. MDR course[India, Europe, USA, ASEAN, ROW markets]
How to Submit a Drug Master File (DMF) in US?
How to Submit an Active Master File (ASMF) in Europe?
DMF preparation in CTD format
Certificate of suitability (COS)
Drug Regulatory System in US
Life Cycle of Drug Product
Drug Regulatory System in EU
Drug Regulatory System in India
Dossier Preparation in CTD/eCTD format
Importance of 21 CFR Part 11
Medical Device Design Process
What is Quality Management System [QMS]?
What is the need for risk management system for Medical Device?
Medical Device Regulation in US
Medical Device Regulation in Europe
Medical Device Regulation in India
Internal Auditor/Lead Auditor QMS 13485-2016, ISO 19011-2018 Course
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Medical Device -Indian Regulation, Bis Submission, Sugam Portal Submission
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Medical Device-European MDR, CE Mark
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Medical Device- USFDA Submission
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Technical File Documentation-Medical Device
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MDD to MDR Implementation
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