This channel's purpose is to share knowledge pertaining to QA, QC, R&D, RA, Manufacturing for the benefit of freshers and the professionals working into the field of Pharmaceuticals, Chemicals, Petrochemicals and academics.
THIS Skill Can Land You a Regulatory Affairs Job in 2026
Did you know that 68% of eCTD submissions face validation errors on the first attempt?
Each rejection means weeks of delays, frustrated teams, and mounting pressure from management.
But what if you could catch every error BEFORE you hit submit?
And if you're a fresher or early starter โ what if mastering this ONE skill could make you the candidate every pharma company wants to hire?
Join me for an exclusive FREE 2-hour live session where Iโll reveal:
๐ FREE LIVE WEBINAR
Common eCTD Validation Errors & How AI Helps You Avoid Them
๐ Date: Wednesday, 18th February 2026
โฐ Time: 7:30 PM to 9:30 PM IST
๐ป Platform: Zoom
๐ก In This Session, Youโll Discover:
โ Top 20 validation errors that cause FDA/EMA rejections
โ AI-powered validation tools that catch errors humans miss
โ Live demo: Fixing real validation errors in real-time
โ Pre-submission checklist used by top generic companies
โ ๏ธ WARNING: Only 50 seats available. Once full, registration closes automatically. Donโt wait until the last minute!
Are you still writing CTD documents the traditional way?
While you spend days drafting Module 2 summaries and weeks compiling Module 3 documentation, AI-equipped professionals are completing the same work in hours.
The gap is widening. Fast.
I invite you to a FREE live webinar where I'll show you exactly how to leverage AI tools for CTD authoringโpractical techniques you can implement immediately.
๐ Date: Sunday, 15th February 2026
๐ Time: 10:00 AM - 12:00 PM IST
๐ Mode: Live Online (Zoom)
๐ WHAT YOU WILL LEARN:
โ AI tools for Module 1, 2, 3, 4 & 5
โ Live demo: AI writing CTD content
โ Free vs paid AI tools
โ How to validate AI-generated content
๐Limited seats (50 only) โ book your spot today.
I am pleased to invite you to an exclusive complimentary webinar on modern regulatory submission practices.
๐ WEBINAR DETAILS:
๐๏ธ Date: Wednesday, 11th February 2026
๐ข Time: 7:30 PM - 9:00 PM IST
๐ป Platform: Zoom
This intensive training session is designed for regulatory affairs professionals, quality assurance personnel, and aspiring candidates seeking to enhance their expertise in US FDA submissions.
โถKEY TAKEAWAYS:
โ Master complete eCTD structure (NDA & ANDA)
โ US Variations
โ Leverage AI tools for faster submissions
โ Avoid common FDA rejection pitfalls
โ Meet 2026 FDA compliance requirements
AI is rapidly changing the regulatory worldโespecially how we compile and review eCTD submissions. With the right approach, AI can help improve efficiency, reduce repetitive work, and support smarter, more streamlined workflows.
If youโd like to understand how AI can be practically used in eCTD compilation and review, join my upcoming webinar.
โถWebinar Topic: Role of AI in eCTD Compilation & Review
โถDate: Sunday, 8th Feb 2026
โถTime: 10:00 AM to 12:00 PM IST
๐What you will learn
โUnderstanding the eCTD structure and regulatory requirements
โAssessing AI technologies for eCTD compilation
โDesigning a data strategy for AI implementation
โImplementing AI tools for submission automation
โValidating AI systems in compliance with regulatory standards
โMonitoring and continuous improvement of AI systems
eCTD Validation: What Regulators Actually Check (US, EU & Canada)
Youโre invited to a FREE live webinar:
eCTD Validation: What Regulators Actually Check (US, EU & Canada)
๐ Date: 4th Feb 2026
๐ข Time: 7:30 PM โ 9:00 PM (IST)
โ Fee: Free (Registration required)
If you are working in Regulatory Affairs or interested to start career in RA, this session will save you from avoidable validation errors, rework, and delays.
What you will learn:
* What regulators actually validate in an eCTD submission
* Common mistakes in XML, folders, file naming, lifecycle, and PDFs
* A simple pre-submission checklist you can use before every sequence
Who should attend
* RA / eCTD / Regulatory Ops professionals
* Freshers who want to learn the right way from day one
* Anyone supporting submissions for US, EU, or Canada
Why you should register now
This is a live session with limited seats to keep the Q&A meaningful.
Register today so you donโt miss the link and reminders.
Many dossiers get queries, rejection, or validation errors not because the data is weak, but because important final checks are missed.
Small inconsistencies across documents and common gaps in Module 2 and Module 3 often become the real reason for delays.
If you want a clear, practical way to confirm whether your dossier is truly ready for submission, this free online session will help you build that clarity with a simple, step-by-step framework.
Webinar Topic: Dossier Preparation & Submission
Date & Time: Sunday, 1st Feb 2026, from 10:00 am to 12:00 pm IST
๐ Key Takeaways:
โ๏ธHow to know your file is submission ready
โ๏ธHow to avoid technical rejection and validation errors
โ๏ธWhat regulators expect in Module 2 & Module 3
โ๏ธA simple framework to check if your dossier is submission-ready
Wishing you a great start to 2026 in advance! ๐
Letโs celebrate the New Year with a new beginning โ by starting (or upgrading) your career in RA.
Today, many pharma companies are actively looking for RA professionals who understand EU regulations because ๐๐๐ฟ๐ผ๐ป๐ด ๐๐ง๐/๐ฒ๐๐ง๐ ๐๐ธ๐ถ๐น๐น๐ help avoid delays and speed up approvals.
And yesโEU regulations are not limited to just one country. They cover 30 countries, with multiple agencies involved such as EC, EMA, EDQM, and NCAs.
Thatโs exactly why EU RA feels more complexโฆ
โฆand thatโs also why it brings better rewards and bigger opportunities.
If youโre interested in learning EU e-submission and module-wise CTD/eCTD preparation, I invite you to attend my upcoming webinar.
๐ Webinar Details
๐ฏ Topic: Hands-On EU eCTD Submission Training for MAA & CEP
๐ Date: Wednesday, 28th Jan 2026
โ Time: 7:30 pm to 9:00 pm IST
Donโt miss this opportunity. Book your seat now!
๐ Key takeaways:
โ๏ธ Understand CTD
โ๏ธ Understand EU / EEA / EFTA
โ๏ธ MAA using eCTD
โ๏ธ CEP requirements & filing
โ๏ธ Career opportunities in RA
Opportunity for QA/QC/RA/R&D/MFG professionals to know how to translate your work into regulatory language.
Excited to meet you during free live session on โHow to Write Strong CMC Sections for eCTDโ.
Webinar Details:
๐ Date: Monday, 26th Jan 2026
โTime: 5:00 pm to 6:30 pm IST
๐Location: Online
๐ฏWhat youโll learn
โ๏ธ What is CTD/eCTD & CMC
โ๏ธTypical CMC deficiencies
โ๏ธ5 golden rules of good CMC writing
โ๏ธCase example: poorly vs well-written section
๐Limited seats (50 only) โ book your spot today.
This session is specially designed for professionals in QA, QC, Manufacturing, R&D and Regulatory to understand how eCTD skills can unlock new career opportunities in Regulatory Affairs.
๐นKey learning outcomes:
โCTD structure for US
โNDA & ANDA
โUS eCTD submission
โCarrer opportunities in RA
Pharma Growth Hub
THIS Skill Can Land You a Regulatory Affairs Job in 2026
Did you know that 68% of eCTD submissions face validation errors on the first attempt?
Each rejection means weeks of delays, frustrated teams, and mounting pressure from management.
But what if you could catch every error BEFORE you hit submit?
And if you're a fresher or early starter โ what if mastering this ONE skill could make you the candidate every pharma company wants to hire?
Join me for an exclusive FREE 2-hour live session where Iโll reveal:
๐ FREE LIVE WEBINAR
Common eCTD Validation Errors & How AI Helps You Avoid Them
๐ Date: Wednesday, 18th February 2026
โฐ Time: 7:30 PM to 9:30 PM IST
๐ป Platform: Zoom
๐ก In This Session, Youโll Discover:
โ Top 20 validation errors that cause FDA/EMA rejections
โ AI-powered validation tools that catch errors humans miss
โ Live demo: Fixing real validation errors in real-time
โ Pre-submission checklist used by top generic companies
โ ๏ธ WARNING: Only 50 seats available. Once full, registration closes automatically. Donโt wait until the last minute!
๐ Register (Free): smartcoach-cc.zoom.us/webinar/register/12177114389โฆ
๐ Join Pharma Community (for Updates): chat.whatsapp.com/EkuqeYc3xHwFWB3FYaZvhR
See you in the session! ๐
Best Regards,
Bhaskar Napte
Indiaโs Leading Pharma Coach
Regulatory Affairs | CTD/eCTD | AI Integration
1 day ago | [YT] | 3
View 0 replies
Pharma Growth Hub
๐๐-๐ฃ๐ผ๐๐ฒ๐ฟ๐ฒ๐ฑ ๐๐ง๐ ๐๐๐๐ต๐ผ๐ฟ๐ถ๐ป๐ด: ๐ช๐ฟ๐ถ๐๐ฒ ๐ ๐ผ๐ฑ๐๐น๐ฒ ๐ญ-๐ฑ ๐๐ผ๐ฐ๐๐บ๐ฒ๐ป๐๐ ๐๐ฎ๐๐๐ฒ๐ฟ ๐๐ถ๐๐ต ๐๐
Are you still writing CTD documents the traditional way?
While you spend days drafting Module 2 summaries and weeks compiling Module 3 documentation, AI-equipped professionals are completing the same work in hours.
The gap is widening. Fast.
I invite you to a FREE live webinar where I'll show you exactly how to leverage AI tools for CTD authoringโpractical techniques you can implement immediately.
๐ Date: Sunday, 15th February 2026
๐ Time: 10:00 AM - 12:00 PM IST
๐ Mode: Live Online (Zoom)
๐ WHAT YOU WILL LEARN:
โ AI tools for Module 1, 2, 3, 4 & 5
โ Live demo: AI writing CTD content
โ Free vs paid AI tools
โ How to validate AI-generated content
๐Limited seats (50 only) โ book your spot today.
๐ Click the Link to Register (Free): smartcoach-cc.zoom.us/webinar/register/40177080059โฆ
๐ Join Community to Receive Training Updates: chat.whatsapp.com/GVkWCJV7du98Nx3XMryNC7
Donโt miss out the opportunity!
Best Regards,
Bhaskar Napte,
Indiaโs Leading Pharma Coach
4 days ago | [YT] | 10
View 0 replies
Pharma Growth Hub
๐๐ฎ๐ป๐ฑ๐-๐ข๐ป ๐ก๐๐ & ๐๐ก๐๐ ๐ฆ๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป ๐ง๐ฟ๐ฎ๐ถ๐ป๐ถ๐ป๐ด ๐๐ถ๐๐ต ๐๐ ๐ง๐ผ๐ผ๐น๐
I am pleased to invite you to an exclusive complimentary webinar on modern regulatory submission practices.
๐ WEBINAR DETAILS:
๐๏ธ Date: Wednesday, 11th February 2026
๐ข Time: 7:30 PM - 9:00 PM IST
๐ป Platform: Zoom
This intensive training session is designed for regulatory affairs professionals, quality assurance personnel, and aspiring candidates seeking to enhance their expertise in US FDA submissions.
โถKEY TAKEAWAYS:
โ Master complete eCTD structure (NDA & ANDA)
โ US Variations
โ Leverage AI tools for faster submissions
โ Avoid common FDA rejection pitfalls
โ Meet 2026 FDA compliance requirements
Kindly register using the link below:
๐ Click Here to Register (Free): smartcoach-cc.zoom.us/webinar/register/20177048032โฆ
๐ Join Community to Receive Training Updates: chat.whatsapp.com/GVkWCJV7du98Nx3XMryNC7
Looking forward to meeting you live!
Best Regards,
Bhaskar Napte
Indiaโs Leading Pharma Coach
#USDrugRegistration #VariationFiling #eCTD #CTD #RegulatoryAffairs #CMC #AI
1 week ago | [YT] | 10
View 0 replies
Pharma Growth Hub
๐ฏ ๐ฅ๐ผ๐น๐ฒ ๐ผ๐ณ ๐๐ฟ๐๐ถ๐ณ๐ถ๐ฐ๐ถ๐ฎ๐น ๐๐ป๐๐ฒ๐น๐น๐ถ๐ด๐ฒ๐ป๐ฐ๐ฒ (๐๐) ๐ถ๐ป ๐ฒ๐๐ง๐ ๐๐ผ๐บ๐ฝ๐ถ๐น๐ฎ๐๐ถ๐ผ๐ป & ๐ฅ๐ฒ๐๐ถ๐ฒ๐
AI is rapidly changing the regulatory worldโespecially how we compile and review eCTD submissions. With the right approach, AI can help improve efficiency, reduce repetitive work, and support smarter, more streamlined workflows.
If youโd like to understand how AI can be practically used in eCTD compilation and review, join my upcoming webinar.
โถWebinar Topic: Role of AI in eCTD Compilation & Review
โถDate: Sunday, 8th Feb 2026
โถTime: 10:00 AM to 12:00 PM IST
๐What you will learn
โUnderstanding the eCTD structure and regulatory requirements
โAssessing AI technologies for eCTD compilation
โDesigning a data strategy for AI implementation
โImplementing AI tools for submission automation
โValidating AI systems in compliance with regulatory standards
โMonitoring and continuous improvement of AI systems
Limited seats!
๐ Register: smartcoach-cc.zoom.us/webinar/register/79177021259โฆ
๐ Join the community to receive training updates: chat.whatsapp.com/GVkWCJV7du98Nx3XMryNC7
Looking forward to meeting you in the session!
Best Regards,
Bhaskar Napte
Indiaโs Leading Pharma Coach
#AI #eCTD #eCTD #Regulations #RA
1 week ago | [YT] | 2
View 0 replies
Pharma Growth Hub
eCTD Validation: What Regulators Actually Check (US, EU & Canada)
Youโre invited to a FREE live webinar:
eCTD Validation: What Regulators Actually Check (US, EU & Canada)
๐ Date: 4th Feb 2026
๐ข Time: 7:30 PM โ 9:00 PM (IST)
โ Fee: Free (Registration required)
If you are working in Regulatory Affairs or interested to start career in RA, this session will save you from avoidable validation errors, rework, and delays.
What you will learn:
* What regulators actually validate in an eCTD submission
* Common mistakes in XML, folders, file naming, lifecycle, and PDFs
* A simple pre-submission checklist you can use before every sequence
Who should attend
* RA / eCTD / Regulatory Ops professionals
* Freshers who want to learn the right way from day one
* Anyone supporting submissions for US, EU, or Canada
Why you should register now
This is a live session with limited seats to keep the Q&A meaningful.
Register today so you donโt miss the link and reminders.
๐ Registration Link: smartcoach-cc.zoom.us/webinar/register/95176992979โฆ
Looking forward to seeing you.
Warm regards,
Bhaskar Napte
Pharma Growth Hub
2 weeks ago | [YT] | 11
View 0 replies
Pharma Growth Hub
๐๐ผ๐๐๐ถ๐ฒ๐ฟ ๐ฃ๐ฟ๐ฒ๐ฝ๐ฎ๐ฟ๐ฎ๐๐ถ๐ผ๐ป & ๐ฆ๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป
Many dossiers get queries, rejection, or validation errors not because the data is weak, but because important final checks are missed.
Small inconsistencies across documents and common gaps in Module 2 and Module 3 often become the real reason for delays.
If you want a clear, practical way to confirm whether your dossier is truly ready for submission, this free online session will help you build that clarity with a simple, step-by-step framework.
Webinar Topic: Dossier Preparation & Submission
Date & Time: Sunday, 1st Feb 2026, from 10:00 am to 12:00 pm IST
๐ Key Takeaways:
โ๏ธHow to know your file is submission ready
โ๏ธHow to avoid technical rejection and validation errors
โ๏ธWhat regulators expect in Module 2 & Module 3
โ๏ธA simple framework to check if your dossier is submission-ready
Limited seats- register now!
๐ ๐ฅ๐ฒ๐ด๐ถ๐๐๐ฒ๐ฟ (๐๐ฟ๐ฒ๐ฒ): smartcoach-cc.zoom.us/webinar/register/21176959860โฆ
๐ Join Pharma Community (Updates): chat.whatsapp.com/GVkWCJV7du98Nx3XMryNC7
See you in the session! ๐
Best Regards,
Bhaskar Napte
Indiaโs Leading Pharma Coach
#RegulatoryAffairs #DossierPreparation #eCTD
2 weeks ago | [YT] | 10
View 0 replies
Pharma Growth Hub
๐๐ฎ๐ป๐ฑ๐-๐ข๐ป ๐๐จ ๐ฒ๐๐ง๐ ๐ฆ๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป ๐ง๐ฟ๐ฎ๐ถ๐ป๐ถ๐ป๐ด ๐ณ๐ผ๐ฟ ๐ ๐๐ & ๐๐๐ฃ
Wishing you a great start to 2026 in advance! ๐
Letโs celebrate the New Year with a new beginning โ by starting (or upgrading) your career in RA.
Today, many pharma companies are actively looking for RA professionals who understand EU regulations because ๐๐๐ฟ๐ผ๐ป๐ด ๐๐ง๐/๐ฒ๐๐ง๐ ๐๐ธ๐ถ๐น๐น๐ help avoid delays and speed up approvals.
And yesโEU regulations are not limited to just one country. They cover 30 countries, with multiple agencies involved such as EC, EMA, EDQM, and NCAs.
Thatโs exactly why EU RA feels more complexโฆ
โฆand thatโs also why it brings better rewards and bigger opportunities.
If youโre interested in learning EU e-submission and module-wise CTD/eCTD preparation, I invite you to attend my upcoming webinar.
๐ Webinar Details
๐ฏ Topic: Hands-On EU eCTD Submission Training for MAA & CEP
๐ Date: Wednesday, 28th Jan 2026
โ Time: 7:30 pm to 9:00 pm IST
Donโt miss this opportunity. Book your seat now!
๐ ๐ฅ๐ฒ๐ด๐ถ๐๐๐ฒ๐ฟ (๐๐ฟ๐ฒ๐ฒ): smartcoach-cc.zoom.us/webinar/register/50176944226โฆ
๐ ๐๐ผ๐ถ๐ป ๐ฃ๐ต๐ฎ๐ฟ๐บ๐ฎ ๐๐ผ๐บ๐บ๐๐ป๐ถ๐๐ (๐จ๐ฝ๐ฑ๐ฎ๐๐ฒ๐): chat.whatsapp.com/EkuqeYc3xHwFWB3FYaZvhR
๐ Key takeaways:
โ๏ธ Understand CTD
โ๏ธ Understand EU / EEA / EFTA
โ๏ธ MAA using eCTD
โ๏ธ CEP requirements & filing
โ๏ธ Career opportunities in RA
See you in the session! ๐
Best Regards,
Bhaskar Napte
Indiaโs Leading Pharma Coach
#RegulatoryAffairs #eCTD #CTD #EURegulations #PharmaCareers
2 weeks ago | [YT] | 9
View 0 replies
Pharma Growth Hub
๐๐ผ๐ ๐๐ผ ๐ช๐ฟ๐ถ๐๐ฒ ๐ฆ๐๐ฟ๐ผ๐ป๐ด ๐๐ ๐ ๐ฆ๐ฒ๐ฐ๐๐ถ๐ผ๐ป๐ ๐ณ๐ผ๐ฟ ๐ฒ๐๐ง๐
Opportunity for QA/QC/RA/R&D/MFG professionals to know how to translate your work into regulatory language.
Excited to meet you during free live session on โHow to Write Strong CMC Sections for eCTDโ.
Webinar Details:
๐ Date: Monday, 26th Jan 2026
โTime: 5:00 pm to 6:30 pm IST
๐Location: Online
๐ฏWhat youโll learn
โ๏ธ What is CTD/eCTD & CMC
โ๏ธTypical CMC deficiencies
โ๏ธ5 golden rules of good CMC writing
โ๏ธCase example: poorly vs well-written section
๐Limited seats (50 only) โ book your spot today.
๐ Click the Link to Register (Free): smartcoach-cc.zoom.us/webinar/register/95176932551โฆ
๐ Join Community to Receive Training Updates: chat.whatsapp.com/EkuqeYc3xHwFWB3FYaZvhR
Donโt miss out the opportunity!
Best Regards,
Bhaskar Napte,
Indiaโs Leading Pharma Coach
#CMC #eCTD #Module3 #Quality #Pharma #Training
3 weeks ago | [YT] | 12
View 0 replies
Pharma Growth Hub
๐ Live Demo: Hands-On eCTD Submission on SMART eCTD
Are you trying to get a job in Regulatory Affairs, but not getting shortlisted?
One common reason is this: many pharma companies expect CTD/eCTD experience.
This gap has stopped many capable professionals from entering Regulatory Affairs.
So, we decided to solve it.
We have developed our own eCTD submission training platform โ SMART eCTD (www.smartectd.com).
With SMART eCTD, you can get hands-on practice in CTD authoring and eCTD submission workflows.
๐ If your goal is to become RA job-ready with real eCTD exposure, please join my upcoming webinar:
๐ Sunday, 25th January 2026
๐ 10:00 AM to 12:00 PM IST
๐ฏ Learning Objectives
โ Understand ICH requirements
โ CTD Triangle
โ eCTD submission & validation
โ eCTD lifecycle management
โ Career opportunities in Regulatory Affairs
This session is ideal for RA aspirants and early-career professionals.
Seats are limited
โ Register Now (Free): smartcoach-cc.zoom.us/webinar/register/20176899125โฆ
๐ฌ Join the community for updates: chat.whatsapp.com/EkuqeYc3xHwFWB3FYaZvhR
See you in the session!
Regards,
Bhaskar Napte
Indiaโs Leading Pharma Coach
3 weeks ago | [YT] | 12
View 0 replies
Pharma Growth Hub
๐๐ฎ๐ป๐ฑ๐-๐ข๐ป ๐จ๐ฆ ๐ฒ๐๐ง๐ ๐ฆ๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป ๐ณ๐ผ๐ฟ ๐ก๐๐ ๐ฎ๐ป๐ฑ ๐๐ก๐๐
Learn the #1 Skill to Get a Job in Regulatory Affairs (RA) Through our eSubmission Platform!
I am happy to invite you to a free live webinar on:
โHands-On US eCTD Submission for NDA and ANDAโ
๐ Wednesday, 21st Jan 2026
๐ ๐ณ:๐ฏ๐ฌ ๐ฝ๐บ ๐๐ผ ๐ต:๐ฌ๐ฌ ๐ฝ๐บ ๐๐ฆ๐ง
This session is specially designed for professionals in QA, QC, Manufacturing, R&D and Regulatory to understand how eCTD skills can unlock new career opportunities in Regulatory Affairs.
๐นKey learning outcomes:
โCTD structure for US
โNDA & ANDA
โUS eCTD submission
โCarrer opportunities in RA
Kindly register using the link below:
๐ ๐๐น๐ถ๐ฐ๐ธ ๐๐ฒ๐ฟ๐ฒ ๐๐ผ ๐ฅ๐ฒ๐ด๐ถ๐๐๐ฒ๐ฟ (๐๐ฟ๐ฒ๐ฒ): smartcoach-cc.zoom.us/webinar/register/26176871990โฆ
๐ Join Community to Receive Training Updates: chat.whatsapp.com/EkuqeYc3xHwFWB3FYaZvhR
After registration, you will receive an email with the webinar link and reminders closer to the event.
Looking forward to meeting you live!
Best Regards,
Bhaskar Napte
Indiaโs Leading Pharma Coach
#USDrugRegistration #VariationFiling #eCTD #CTD #RegulatoryAffairs #CMC
4 weeks ago | [YT] | 9
View 0 replies
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