Pharma Growth Hub

𝗛𝗮𝗻𝗱𝘀-𝗢𝗻 𝗘𝗨 𝗲𝗖𝗧𝗗 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗧𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗳𝗼𝗿 𝗠𝗔𝗔 & 𝗖𝗘𝗣

Wishing you a great start to 2026 in advance! 🎉

Let’s celebrate the New Year with a new beginning — by starting (or upgrading) your career in RA.

Today, many pharma companies are actively looking for RA professionals who understand EU regulations because 𝘀𝘁𝗿𝗼𝗻𝗴 𝗖𝗧𝗗/𝗲𝗖𝗧𝗗 𝘀𝗸𝗶𝗹𝗹𝘀 help avoid delays and speed up approvals.

And yes—EU regulations are not limited to just one country. They cover 30 countries, with multiple agencies involved such as EC, EMA, EDQM, and NCAs.

That’s exactly why EU RA feels more complex…
…and that’s also why it brings better rewards and bigger opportunities.

If you’re interested in learning EU e-submission and module-wise CTD/eCTD preparation, I invite you to attend my upcoming webinar.

📌 Webinar Details
🎯 Topic: Hands-On EU eCTD Submission Training for MAA & CEP
📅 Date: Thursday, 1st Jan 2026
⌚ Time: 7:30 pm to 9:00 pm IST

Don’t miss this opportunity. Book your seat now!

👉 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 (𝗙𝗿𝗲𝗲): smartcoach-cc.zoom.us/webinar/register/93176688889…

👉 𝗝𝗼𝗶𝗻 𝗣𝗵𝗮𝗿𝗺𝗮 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆 (𝗨𝗽𝗱𝗮𝘁𝗲𝘀): chat.whatsapp.com/EkuqeYc3xHwFWB3FYaZvhR

🚀 Key takeaways:
☑️ Understand CTD
☑️ Understand EU / EEA / EFTA
☑️ MAA using eCTD
☑️ CEP requirements & filing
☑️ Career opportunities in RA

See you in the session! 🙂

Best Regards,
Bhaskar Napte
India’s Leading Pharma Coach
#RegulatoryAffairs #eCTD #CTD #EURegulations #PharmaCareers

3 days ago | [YT] | 8

Pharma Growth Hub

𝗨𝗦 𝗗𝗿𝘂𝗴 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗩𝗮𝗿𝗶𝗮𝘁𝗶𝗼𝗻 𝗙𝗶𝗹𝗶𝗻𝗴 𝗨𝘀𝗶𝗻𝗴 𝗲𝗖𝗧𝗗

I am happy to invite you to a free live webinar on:

“𝗨𝗦 𝗗𝗿𝘂𝗴 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 & 𝗩𝗮𝗿𝗶𝗮𝘁𝗶𝗼𝗻 𝗙𝗶𝗹𝗶𝗻𝗴 𝗨𝘀𝗶𝗻𝗴 𝗲𝗖𝗧𝗗”
📅 Wednesday, 𝟮𝟰𝘁𝗵 𝗗𝗲𝗰𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟱
🕙 𝟳:𝟯𝟬 𝗽𝗺 𝘁𝗼 𝟵:𝟬𝟬 𝗽𝗺 𝗜𝗦𝗧

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.

🔹𝗞𝗲𝘆 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀:
✔US drug registration pathways
✔CTD structure used for US submissions
✔US post-approval changes (variations)
✔eCTD lifecycle

Kindly register using the link below:

👉 𝗖𝗹𝗶𝗰𝗸 𝗛𝗲𝗿𝗲 𝘁𝗼 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 (𝗙𝗿𝗲𝗲): smartcoach-cc.zoom.us/webinar/register/65176620435…

👉 Join Community to Receive Training Updates: chat.whatsapp.com/Dh8NMEUpZLW3G1pTo08Qfo

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
India’s Leading Pharma Coach


#USDrugRegistration #VariationFiling #eCTD #CTD #RegulatoryAffairs #CMC

1 week ago | [YT] | 13

Pharma Growth Hub

🚀𝐇𝐚𝐧𝐝𝐬-𝐎𝐧 𝐂𝐓𝐃 𝐏𝐫𝐞𝐩𝐚𝐫𝐚𝐭𝐢𝐨𝐧 & 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠

I’m conducting a free, 90-minute hands-on CTD training, to help you get job-ready for Regulatory Affairs.

🗓️ Wednesday, 17th Dec 2025| ⏰ 7:30–9:00 PM IST
🎟️ Only 50 seats | First-come

🎯Learning Objectives:
✅Understand crucial ICH requirements
✅Create Module 1 to 5 documents
✅Assemble a basic eCTD sequence
✅Create & verify the eCTD XML backbone
✅SPL preparation & validation

This training is ideal for Regulatory Affairs aspirants and early-career professionals.

👉 Register now (50 seats): smartcoach-cc.zoom.us/webinar/register/14176567326…

📌 Join Community to Receive Training Updates: chat.whatsapp.com/EKboNFuvbou7uVYUOYui3b

Look forward to meeting you in the session!

Warm Regards,
Bhaskar Napte
India’s Leading Pharma Coach


#eCTD #RegulatoryAffairs #CTD #PharmaCareers #DrugRegulatory #DossierPublishing #PharmaGrowthHub

2 weeks ago | [YT] | 10

Pharma Growth Hub

𝗛𝗮𝗻𝗱𝘀-𝗢𝗻 𝗘𝗨 𝗲𝗖𝗧𝗗: 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗮𝗻𝗱 𝗟𝗶𝗳𝗲𝗰𝘆𝗰𝗹𝗲 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀

If you are planning to start your career in Regulatory Affairs,
thinking to switch from your current domain to RA,
or already in RA but want to upskill in eCTD and dossier authoring,
this online webinar will be very useful for you.

𝗪𝗲𝗯𝗶𝗻𝗮𝗿 𝗗𝗲𝘁𝗮𝗶𝗹𝘀:
🎯Topic: Hands-On EU eCTD: Submission Strategy and Lifecycle Operations
📅Date: Sunday, 14th Dec 2025
⌚Time: 10:00 am to 12:00 pm IST
📍Location: Online

👉 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀:
☑️CTD and eCTD for EU submissions
☑️EU-specific requirements for eCTD
☑️eCTD lifecycle operations
☑️Career Opportunities

𝗪𝗵𝘆 𝘁𝗵𝗶𝘀 𝘄𝗲𝗯𝗶𝗻𝗮𝗿 𝗶𝘀 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗳𝗼𝗿 𝘆𝗼𝘂𝗿 𝗥𝗔 𝗰𝗮𝗿𝗲𝗲𝗿/𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝗻𝗰𝘆?
✔Understanding of CTD / eCTD structure
✔Ability to author and review Module 1-5 content
✔Knowledge of eCTD sequences, lifecycle, and variations

Book your seat now!

👉 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 (𝗙𝗿𝗲𝗲): smartcoach-cc.zoom.us/webinar/register/33176536025…

👉 Join Community to Receive Training Updates: chat.whatsapp.com/G2ViVRp6w5pAJlE4gnp2pk

See you in the session!

𝗕𝗲𝘀𝘁 𝗥𝗲𝗴𝗮𝗿𝗱𝘀,
Bhaskar Napte
India’s Leading Pharma Coach


#RegulatoryAffairs #eCTD #EUECTD #PharmaCareers #PharmaGrowthHub

3 weeks ago | [YT] | 11

Pharma Growth Hub

🚀 𝗖𝗧𝗗/𝗲𝗖𝗧𝗗: 𝗦𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲, 𝗗𝗼𝘀𝘀𝗶𝗲𝗿 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀 & 𝗖𝗮𝗿𝗲𝗲𝗿 𝗣𝗮𝘁𝗵

eCTD has become the standard format for regulatory submissions across the globe – but for many QA, QC, Manufacturing, R&D and even RA professionals, the actual structure, documents and submission flow still feel abstract.

This webinar is designed to give you a clear, practical understanding of:
• how a CTD / eCTD dossier is structured,
• which documents go where, and
• how this knowledge can support your career growth – whether you stay in your current function or move towards Regulatory Affairs roles.

📅 Date: Wednesday, 10th Dec 2025
⏰ Time: 730 pm to 9:00 pm IST

👉 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗼𝗯𝗷𝗲𝗰𝘁𝗶𝘃𝗲:
✔ CTD/ eCTD framework
✔ CTD / eCTD key documents
✔ eCTD submission
✔ eCTD lifecycle management

We will start from basics and gradually build up to a practical, working-level understanding.

🔗 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 (𝗙𝗿𝗲𝗲): smartcoach-cc.zoom.us/webinar/register/51176498390…

🎓Join Community to Receive Training Updates: chat.whatsapp.com/Dh8NMEUpZLW3G1pTo08Qfo

Looking forward to meeting you live!

Best Regards,
Bhaskar Napte
India’s Leading Pharma Coach

3 weeks ago | [YT] | 14

Pharma Growth Hub

𝗨𝗦 𝗗𝗿𝘂𝗴 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗩𝗮𝗿𝗶𝗮𝘁𝗶𝗼𝗻 𝗙𝗶𝗹𝗶𝗻𝗴 𝗨𝘀𝗶𝗻𝗴 𝗲𝗖𝗧𝗗

I am happy to invite you to a free live webinar on:

“𝗨𝗦 𝗗𝗿𝘂𝗴 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 & 𝗩𝗮𝗿𝗶𝗮𝘁𝗶𝗼𝗻 𝗙𝗶𝗹𝗶𝗻𝗴 𝗨𝘀𝗶𝗻𝗴 𝗲𝗖𝗧𝗗”
📅 𝗦𝘂𝗻𝗱𝗮𝘆, 𝟳𝘁𝗵 𝗗𝗲𝗰𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟱
🕙 𝟭𝟬:𝟬𝟬 𝗮𝗺 𝘁𝗼 𝟭𝟮:𝟬𝟬 𝗽𝗺 𝗜𝗦𝗧

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.

🔹𝗞𝗲𝘆 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀:
✔US drug registration pathways
✔CTD structure used for US submissions
✔US post-approval changes (variations)
✔eCTD lifecycle

Kindly register using the link below:

👉 𝗖𝗹𝗶𝗰𝗸 𝗛𝗲𝗿𝗲 𝘁𝗼 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 (𝗙𝗿𝗲𝗲): smartcoach-cc.zoom.us/webinar/register/38176474846…

👉 Join Community to Receive Training Updates: chat.whatsapp.com/Dh8NMEUpZLW3G1pTo08Qfo

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
India’s Leading Pharma Coach


#USDrugRegistration #VariationFiling #eCTD #CTD #RegulatoryAffairs #CMC

4 weeks ago | [YT] | 8

Pharma Growth Hub

𝗛𝗼𝘄 𝘁𝗼 𝗪𝗿𝗶𝘁𝗲 𝗦𝘁𝗿𝗼𝗻𝗴 𝗖𝗠𝗖 𝗦𝗲𝗰𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗲𝗖𝗧𝗗

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 “How to Write Strong CMC Sections for eCTD”.

Webinar Details:
📅Date: Wednesday, 3rd Dec 2025
⌚Time: 7:30 pm to 9:00 pm IST
📍Location: Online

🎯What you’ll learn
☑️ What is CTD/eCTD & CMC
☑️Typical CMC deficiencies
☑️5 golden rules of good CMC writing
☑️Case example: poorly vs well-written section

📍Limited seats (50 only) — book your spot today.

👉 Click the Link to Register (Free): smartcoach-cc.zoom.us/webinar/register/84176447525…

👉 Join Community to Receive Training Updates: chat.whatsapp.com/Dh8NMEUpZLW3G1pTo08Qfo

Don’t miss out the opportunity!

Best Regards,
Bhaskar Napte,
India’s Leading Pharma Coach

#CMC #eCTD #Module3 #Quality #Pharma #Training

1 month ago | [YT] | 9

Pharma Growth Hub

𝗛𝗮𝗻𝗱𝘀-𝗢𝗻 𝗲𝗖𝗧𝗗 𝗣𝗿𝗲𝗽𝗮𝗿𝗮𝘁𝗶𝗼𝗻 & 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 – 𝗚𝗲𝘁 𝗝𝗼𝗯 𝗥𝗲𝗮𝗱𝘆 𝗳𝗼𝗿 𝗥𝗔!

Strong skills in CTD document writing and eCTD submission are key to getting hired in Regulatory Affairs.

If you want real, practical experience in both, join our upcoming free webinar.

📌 Webinar Details
📅 Date: Sunday, 30th Nov 2025
⏰ Time: 10:00 am – 12:00 pm IST
💻 Mode: Online

🎯 You will learn:
☑️ The CTD “triangle”
☑️ CTD document writing
☑️ eCTD submission and validation
☑️ eCTD lifecycle management

📍Only 50 seats available – reserve your seat now!

This session is designed to speed up your journey to a Regulatory Affairs job by giving you hands-on, practical exposure.

👉 Register (Free): smartcoach-cc.zoom.us/webinar/register/41176415443…

👉 Community for Training Updates: chat.whatsapp.com/G2ViVRp6w5pAJlE4gnp2pk

Don’t miss this opportunity to upgrade your RA career skills!

Best regards,
Bhaskar Napte
India’s Leading Pharma Coach

#RegulatoryAffairs #eCTD #CTDWriting #PharmaCareer #PharmaJobs #PharmaTraining #HandsOnLearning #PharmaProfessionals #PharmaceuticalIndustry #PharmaGrowthHub

1 month ago | [YT] | 10

Pharma Growth Hub

🚀 𝗙𝗿𝗼𝗺 𝗖𝗧𝗗 𝘁𝗼 𝗲𝗖𝗧𝗗 𝘃𝟰: 𝗪𝗵𝗮𝘁’𝘀 𝗖𝗵𝗮𝗻𝗴𝗶𝗻𝗴 𝗮𝗻𝗱 𝗛𝗼𝘄 𝘁𝗼 𝗣𝗿𝗲𝗽𝗮𝗿𝗲 𝗡𝗼𝘄

We keep hearing that eCTD v4 is coming, but many of us are still unclear about what exactly will change and how to get ready.

To help you with this, I’m conducting a free 90-minute live webinar on eCTD v4.

🗓️ Wednesday, 26th Nov 2025
⏰ 7:30 – 9:00 PM IST
🎟️ Only 50 seats (first-come, first-served)

🎯 Learning Objectives:
✅ eCTD v3.2.2 vs eCTD v4
✅ What remains the same
✅ What is changing in eCTD v4
✅ eCTD submission checklist

This session is especially useful for Regulatory Affairs aspirants and early-career professionals who want clarity and confidence in eCTD submissions.

👉 Register now (limited to 50 seats): smartcoach-cc.zoom.us/webinar/register/98176388365…

📌 Join PGH Community: chat.whatsapp.com/G2ViVRp6w5pAJlE4gnp2pk

Looking forward to meeting you in the session!

Warm regards,
Bhaskar Napte
India’s Leading Pharma Coach

#eCTD #RegulatoryAffairs #CTD #PharmaCareers #DrugRegulatory #DossierPublishing #PharmaGrowthHub

1 month ago | [YT] | 9

Pharma Growth Hub

𝗲𝗖𝗧𝗗 𝗲𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹𝘀 𝗳𝗼𝗿 𝗔𝗡𝗗𝗔/𝟱𝟬𝟱(𝗯)(𝟮)

This focused session is designed for Regulatory Affairs, CMC, QA/QC and ARD professionals who want to understand how US ANDA and 505(b)(2) dossiers are structured and submitted in eCTD format.

Webinar Details:
📅Date: Sunday, 23rd Nov 2025
⌚Time: 10:00 am to 12:00 pm
📍Location: Online

👉 Click Here to Register (Free): smartcoach-cc.zoom.us/webinar/register/50176354800…

👉 Join Community to Receive Training Updates: chat.whatsapp.com/G2ViVRp6w5pAJlE4gnp2pk

👉 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀:
☑️ US Generic & 505(b)(2)
☑️ Module 2 & 3 for ANDA/505(b)(2)
☑️ US eCTD submissions
☑️ Common mistakes in US eCTD

Don't miss this opportunity!

Best Regards,
Bhaskar Napte
India’s Leading Pharma Coach

#US #NDA #ANDA #505b2 #DrugRegulation #eCTD

1 month ago | [YT] | 5