Name: Medical Device & IVD Regulatory Affairs Masterclass
Brand: STENOVA MEDEX

Stenova Medex Private Limited is a pharmaceutical consulting and healthcare solutions company committed to supporting the global pharmaceutical and cosmetic industries through comprehensive regulatory, export, and professional training services.

We specialize in Regulatory Affairs Consultancy, assisting pharmaceutical and cosmetic companies with product registration, dossier compilation, CTD/ACTD/eCTD submissions, regulatory compliance, labeling review, and global market authorization support. Our mission is to simplify complex regulatory pathways and help clients achieve faster market access with complete compliance. The company's website highlights services such as CTD/eCTD filing, Drug Master Files, regulatory strategy, labeling & artwork, and global submissions.

In addition to consultancy services, we are actively engaged in the export of pharmaceutical products and cosmetics, connecting high-quality healthcare products with international markets while ensuring adherence to country-specific regulatory requirements and quality standards.

Stenova Medex also operates a dedicated E-Learning Academy, offering industry-focused training programs in Regulatory Affairs, CTD/ACTD dossier preparation, pharmaceutical documentation, global regulatory guidelines, and other professional development courses. Our practical training programs are designed to bridge the gap between academic knowledge and industry expectations, helping students and professionals build successful careers in the pharmaceutical sector.

Our Core Services

Regulatory Affairs Consultancy
CTD/ACTD/eCTD Dossier Preparation
Global Product Registration Support
Pharmaceutical & Cosmetic Export
Regulatory Documentation & Compliance
E-Learning & Professional Training Programs

Our Vision
To become a trusted global partner in pharmaceutical regulatory consulting, international healthcare trade, and professional education by delivering excellence, compliance, and innovation.

Our Mission
To empower pharmaceutical businesses and professionals with reliable regulatory solutions, quality export services, and industry-relevant education that drives global healthcare success.

Bond To Thrive

Stenova Medex Private Limited

<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

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.