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Courses
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Biomedical Industrial and Academic Training
- Certification Course in Medical Device Quality Management System
- Certification Course in QMS Documentation of Medical Devices
- ISO 13485:2016 Internal Auditor Course
- IRCA-CQI Approved ISO 13485:2016 Lead Auditor Course
- Certification Course in Biomedical Equipment Installation & Servicing
- Certification Course in IVD Medical Devices Installation & Servicing
- Certification Course to Become Expert in Single Point Department
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Regular Professional Certification Courses
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Pharmaceutical
- Advanced Course in GLOBAL REGULATORY AFFAIRS
- REGULATORY AFFAIRS-Formulation
- REGULATORY AFFAIRS-API [DMF/ASMF/CEP]
- QA-QM [Quality Assurance and Quality Management]
- Regulatory Submissions as per CTD-eCTD, ACTD, NeeS
- Advanced Course in Clinical Research [CR]
- Advanced Course in 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]
- Stability Testing in Pharmaceuticals
- Effective CMC Writing and Review Skills
- Nutraceuticals
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Medical Device
- GLOBAL Medical Devices Regulations (India, Europe, USA, ASEAN, ROW Markets)
- Medical Device-Quality Assurance
- Internal Auditor/Lead Auditor QMS 13485-2016, ISO 19011-2018 Course
- Medical Device - Indian Regulation, BIS Submission, Sugam Portal Submission
- Medical Device-European MDR, CE Mark
- Medical Device- USFDA Submission
- MDD to MDR Implementation
- Medical Device-Risk Management
- Implementation of MDSAP, An Overview
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Pharmaceutical
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eLearning Short Courses
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Medical Device
- Biologics/Biosimilar Submission as per US and EU
- Medical Device Labeling as per EU and ISO 15223
- Pharmaceutical Product Labeling as US, EU, and India
- Computer System Validation, 21 CFR part 11, GAMP 5
- Internal Auditor/Lead Auditor QMS 13485-2016, ISO 19011-2018 Course
- Medical Device - Indian Regulation, BIS Submission, Sugam Portal Submission
- Medical Device-European MDR, CE Mark
- Medical Device- USFDA Submission
- MDD to MDR Implementation
- Medical Device-Risk Management
- Medical Device Design and Development
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Pharmaceutical
- Effective CMC Writing and Review Skills
- Drug Regulation In US
- Drug Regulation in Europe
- Drug Regulation in ROW
- Drug Substance Regulation-Drug Master File
- Formulation Development
- Drug Development Process
- Good Manufacturing Practice
- Regulatory System in Canada
- ICH Q1-Stability Studies
- ICH Q2-Analytical Validation
- ICH Q3-Impurities
- ICH Q6-Specification
- ICH Q9-Quality Risk Management
- ICH Q10-Pharmaceutical Quality Management
- Importance of Data Integrity in Pharmaceuticals
- Nutraceuticals
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Medical Device
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Biomedical Industrial and Academic Training
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