Karthikeyan R’s Post

Time is running out! Have you registered for Freyr’s free webinar on “Overview of PMDA Clinical Trial Consultation”, scheduled for October 15, 2024? Register now to gain an in-depth perspective on the Regulatory expectations and challenges to expand your footprint in Japan. https://lnkd.in/gumnad_G #Japan #MedicinalProducts #Pharmaceuticals #clinicaltrial #Freyr #FreeWebinar #Webinar #RegulatoryAffairs 

𝐋𝐚𝐬𝐭-𝐦𝐢𝐧𝐮𝐭𝐞 𝐫𝐞𝐦𝐢𝐧𝐝𝐞𝐫! Just a day left for Freyr’s free webinar on 𝐎𝐯𝐞𝐫𝐯𝐢𝐞𝐰 𝐨𝐟 𝐏𝐌𝐃𝐀 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐭𝐢𝐨𝐧. Register now to gain an in-depth perspective on Regulatory expectations and challenges. https://lnkd.in/gumnad_G #Japan #MedicinalProducts #Pharmaceuticals #clinicaltrial #FreeWebinar #Webinar #RegulatoryAffairs

𝐋𝐚𝐬𝐭-𝐦𝐢𝐧𝐮𝐭𝐞 𝐫𝐞𝐦𝐢𝐧𝐝𝐞𝐫! Just a day left for Freyr’s free webinar on 𝐎𝐯𝐞𝐫𝐯𝐢𝐞𝐰 𝐨𝐟 𝐏𝐌𝐃𝐀 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐭𝐢𝐨𝐧. Register now to gain an in-depth perspective on Regulatory expectations and challenges. https://lnkd.in/gumnad_G    #Japan #MedicinalProducts #Pharmaceuticals #clinicaltrial #Freyr #FreeWebinar #Webinar #RegulatoryAffairs

Beyond IDMP – Act Now to Reap the Benefits of eCTD 4.0 Compliance Read how here - https://lnkd.in/g--6dnPz #eCTD4 #RegulatoryCompliance #Pharmaceuticals #DataManagement #ComplianceStandards #PharmaceuticalOutsourcing

Stay informed with the latest from the FDA! The FDA has issued a Technical Conformance Guide to assist registrants of drug establishments in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. This guide is a crucial resource for industry professionals, providing clear instructions on how to access the FDA’s CDER NextGen Portal and submit these reports. Stay ahead of the curve by understanding the data elements to be included in the reports. #fda #fdacompliance #pharmaceuticals #regulatorycompliance #drugmanufacturing #shenclinicalservices Read More: https://lnkd.in/eg7qD3ZY

Please join me on this webinar to get an insight on Promotional communications

Does your computerized system need to comply with 21 CFR Part 11? I’ve created a presentation outlining the key considerations for assessing Part 11 applicability. #compliance #21CFRPart11 #GMP #pharmaceutical

Welcome to the DrugPatentWatch Week in Review! This week, we’ve gathered the most insightful updates on drug patents, industry trends, and regulatory changes. Stay ahead with our expert analysis and ensure you’re fully informed about the pharmaceutical landscape. #DrugPatents #PharmaNews #IndustryTrends

How have regulatory approval timelines in major markets changed over time? Take a look at our new six-agency briefing to find out.   The briefing provides insights into regulatory performance across these six major jurisdictions from 2014-2023 and examines the impact of facilitated regulatory pathways on new active substance approvals. Download the briefing >> https://lnkd.in/ewv_nCsN #RegulatoryScience #pharmaceuticals #RegulatoryAffairs #drugdevelopment #EMA #FDA #PMDA #TGA #Swissmedic #HealthCanada

On the safe side: Fulfilling the FDA’S 21 CFR Part 11 requirements using testo Saveris Pharma Solutions. Download the whitepaper now: https://lnkd.in/eKDDpbEc #Pharmaceuticals #QualityAssurance #EnvironmentalMonitoring #testopharmasolutions #21CFR11