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Want to understand&nbsp;Medical Device &amp; IVD Regulatory Affairs in India&nbsp;and learn how Medical Devices and IVDs are regulated, classified, registered, imported and manufactured? The&nbsp;Medical Device &amp; IVD Regulatory Affairs Masterclass&nbsp;is a&nbsp;video + PDF-based course&nbsp;designed to help you build a strong understanding of the Indian regulatory framework for Medical Devices and In Vitro Diagnostic Devices (IVDs). <h3>What You’ll Learn</h3>✅ Medical Devices &amp; IVDs – definitions and concepts ✅ Medical Device Rules (MDR), 2017 ✅ CDSCO and State Licensing Authorities ✅ Medical Device &amp; IVD Classification – Class A, B, C &amp; D ✅ Regulatory requirements according to device classification ✅ Notified Bodies and their role ✅ SUGAM Portal registration and regulatory processes ✅ Manufacturing License requirements for Medical Devices ✅ Import License requirements for Medical Devices &amp; IVDs ✅ Different MD application and license forms ✅ Predicate Device concept ✅ MD-14 checklist and important regulatory documents ✅ Device Master File (DMF) – purpose, importance &amp; contents ✅ Regulatory pathway when a Predicate Device is available or not available in India ✅ Post-approval requirements and PSUR <h3>Who Should Take This Course?</h3>This masterclass is suitable for:• B.Pharm / M.Pharm / Pharm.D students &amp; graduates • Regulatory Affairs professionals • QA/QC professionals • Medical Device professionals • Freshers looking to enter Medical Device Regulatory Affairs • Professionals who want to understand Medical Device &amp; IVD registration in India <h3>Course Format</h3>🎥 Video-Based Learning – Learn concepts through easy-to-understand video lessons 📚 PDF Study Material – Detailed PDFs for learning and future reference 🎯 Practical Regulatory-Focused Content 🇮🇳 Focused on Indian Medical Device &amp; IVD Regulations ⏰ Learn Anytime, AnywhereBuild a strong understanding of Medical Device &amp; IVD Regulatory Affairs, CDSCO requirements, device classification, SUGAM processes, licensing, import requirements and regulatory documentation.Start your journey into Medical Device &amp; IVD Regulatory Affairs today.

Medical Device & IVD Regulatory Affairs Masterclass

Are you a Pharmacy Student, Fresher, Regulatory Affairs Professional, or Industry Aspirant looking to understand CTD &amp; ACTD dossier formats practically?The CTD &amp; ACTD Dossier Reference Pack is designed to help you understand the structure and organization of regulatory dossiers used for pharmaceutical product registrations across global markets.This reference pack provides sample CTD and ACTD dossier formats that can be used for learning, self-study, and professional reference, making it easier to build a strong foundation in Regulatory Affairs documentation.✅ What's Included<ul><li>📄 CTD Sample Dossier Format</li><li>📄 ACTD Sample Dossier Format </li><li>📖 Easy-to-understand document structure</li><li>⚡ Instant access after successful payment</li></ul>❌ Not Included<ul><li>Regulatory Affairs Accelerator Course</li><li>Certificate of Completion</li><li>Live Training Sessions</li></ul>👨‍🎓 Perfect For<ul><li>Pharmacy Students</li><li>B.Pharm &amp; M.Pharm Graduates</li><li>Regulatory Affairs Freshers</li><li>QA/QC Professionals</li><li>Pharmaceutical Industry Professionals</li><li>Anyone interested in learning CTD &amp; ACTD dossier formats</li></ul>🎯 What You Will Learn<ul><li>Understanding CTD dossier structure</li><li>Understanding ACTD dossier structure</li><li>Document organization and formatting</li><li>Module-wise dossier arrangement</li><li>Practical reference for regulatory documentation</li><li>Foundation for a career in Regulatory Affairs</li></ul>

CTD & ACTD Dossier Reference Pack

Build Strong Regulatory Affairs Fundamentals &amp; Job-Oriented KnowledgeThe Regulatory Affairs Foundation Program is a comprehensive self-paced learning program designed for pharmacy students, freshers, QA/QC professionals, R&amp;D professionals, and aspiring Regulatory Affairs specialists who want to build a strong foundation in pharmaceutical regulatory affairs.This program covers the , including CTD/ACTD dossier structure, global regulatory pathways, and essential regulatory concepts required to start a successful career in the pharmaceutical industry. The course is designed with practical examples and easy-to-understand study materials, enabling learners to study at their own pace and gain industry-relevant knowledge. ✅ What You'll Learn<ul><li>Fundamentals of Pharmaceutical Regulatory Affairs</li><li>Understanding CTD &amp; ACTD Dossier Structure</li><li>Global Regulatory Pathways (US, EU, India &amp; Emerging Markets)</li><li>Essential Regulatory Guidelines &amp; Documentation</li><li>Practical Regulatory Affairs Concepts</li><li>Job-Oriented Knowledge for Career Growth</li></ul>📚 Course Includes<ul><li>10 Structured Learning Modules</li><li>Regulatory Affairs Basics</li><li>CTD/ACTD Structure Understanding</li><li>Regulatory Pathways (US, EU, India &amp; Emerging Markets)</li><li>Practical Examples</li><li>Expert Guidance</li><li>Lifetime Access</li><li>Self-Paced Learning</li></ul>👨‍🎓 Ideal For<ul><li>B.Pharm &amp; M.Pharm Students</li><li>Regulatory Affairs Freshers</li><li>QA/QC Professionals</li><li>R&amp;D Professionals</li><li>Pharmaceutical Industry Professionals</li><li>Anyone looking to start a career in Regulatory Affairs</li></ul><h3>❌ Not Included</h3><ul><li>CTD &amp; ACTD Sample Dossier Formats</li><li>Course Completion Certificate</li></ul><h3>🎯 Course Objective</h3>This program aims to provide learners with a strong conceptual foundation in Regulatory Affairs, helping them understand pharmaceutical regulations, dossier structures, and international regulatory pathways while preparing them for entry-level opportunities in the Regulatory Affairs domain.

Regulatory Affairs Foundation Program

<h1>🚀 Become a Job-Ready Pharma Regulatory Affairs Professional</h1><h3>Learn CTD, ACTD, DMF &amp; Global Regulatory Submissions with Real Industry Dossiers</h3>✅ 10 Practical Modules ✅ Real CTD &amp; ACTD Sample Dossiers ✅ Lifetime Access ✅ Certificate of Completion ✅ Learn Anytime, Anywhere ✅ Only ₹499 (Launch Offer)<h2>Are You Struggling To Get A Regulatory Affairs Job?</h2>❌ No practical knowledge❌ College teaches theory only❌ Don't know CTD &amp; ACTD❌ No idea how dossiers are prepared❌ Companies ask for experience<h3>You're not alone...</h3>Thousands of pharmacy graduates face the same problem.This course bridges the gap between college education and industry requirements.Learn Directly From Industry ExperienceThis course is designed by professionals working in pharmaceutical regulatory consulting.You'll learn:<ul><li>CTD Preparation</li><li>ACTD Preparation</li><li>DMF Preparation</li><li>Global Submission Process</li><li>USFDA</li><li>EU</li><li>ASEAN</li><li>India</li><li>Emerging Markets</li></ul>Course Curriculum<h3>Module 1</h3>Introduction to Regulatory Affairs<h3>Module 2</h3>ICH Guidelines &amp; CTD Structure<h3>Module 3</h3>Drug Master File (DMF)<h3>Module 4</h3>CTD Dossier Preparation<h3>Module 5</h3>USFDA Submission<h3>Module 6</h3>European Submission<h3>Module 7</h3>API Regulatory Submission<h3>Module 8</h3>Emerging Markets<h3>Module 9</h3>India Regulatory Submission<h3>Module 10</h3>Advanced Regulatory TopicsBonus Worth ₹5000+🎁 Bonus 1Real CTD Sample Dossier🎁 Bonus 2 Real ACTD Sample DossierWhat You'll Receive✅ 10 PDF Modules✅ Certificate✅ CTD Sample✅ ACTD Sample✅ Lifetime Access✅ Instant Access✅ Mobile Friendly <h1>Who Should Join?</h1>Perfect for:✔ B.Pharm Students✔ M.Pharm Students✔ Pharm.D✔ Fresh Graduates✔ QA Professionals✔ QC Professionals✔ Production Professionals✔ Pharma Job SeekersCourse Value <h1>Why Buy This Course?</h1>Instead of learning from random YouTube videos...Learn the complete process in one structured program with practical examples.

Regulatory Affairs Career Accelerator

STENOVA MEDEX