RegASK

🔍 Regulatory News | New FDA Pilot Program that Could Reshape U.S. Generic Drug Manufacturing   The U.S. FDA has introduced a new pilot program to prioritize review of generic drug applications made and tested entirely in the U.S.   By promoting domestic manufacturing and sourcing, the initiative aims to accelerate approval timelines, reduce foreign dependency, and strengthen supply chain resilience, marking a major step toward a more secure and sustainable pharmaceutical ecosystem.   Discover what this means for manufacturers, regulators, and patients, and how AI-driven regulatory intelligence can help organizations stay ahead of evolving FDA initiatives.   👉 Read the full update: https://lnkd.in/gkia2bJE 👉 Stay ahead with AI-driven Regulatory Intelligence. Book a demo with RegASK: https://lnkd.in/dZt2KkiB   #RegASK #RegTech #RegulatoryIntelligence #AiinRegulatoryAffairs #RegulatoryInnovation #LifeSciences #Pharma #Compliance #FDA #GenerativeAI #AgenticAI Anum Mukhtar, Kelli Madden, Remie Abdel Latif, Khushi Gupta, Oliver Stein, Josh Lambeth, MBA, Zach Poole, Fabienne JAUTARD

🌸 RegASK at the Global Fragrance Summit 2025 | Reflections and Takeaways RegASK joined global fragrance and regulatory leaders at the The International Fragrance Association (IFRA) Global Fragrance Summit in Singapore, where our Directors Remie Abdel Latif and Oliver Stein connected with innovators shaping the future of the fragrance industry.   Over the two days of discussion, several themes stood out: 1⃣ Regulations spark innovation: Stricter rules are inspiring fragrance companies to think creatively and develop smarter, safer solutions. 2⃣ Collaboration drives progress: True growth happens when companies and regulators align early to harmonize standards and uphold shared safety goals. 3⃣ AI is reshaping fragrance: From compliance to reformulation and scent discovery, AI is transforming many links in the value chain. 4⃣ Asia the new fragrance innovation hub: The region is emerging as a pioneer of new creations and a driver of global regulatory standards through transparency and collaboration.   A special thank you to The International Fragrance Association (IFRA), the organizing team, speakers, and fellow participants for putting together such a forward-looking event. 👉 Stay ahead with AI-driven Regulatory Intelligence. Book a demo with RegASK: https://lnkd.in/dZt2KkiB #RegASK #RegTech #RegulatoryIntelligence #AiinRegulatoryAffairs #RegulatoryInnovation #Compliance #FragranceIndustry #LifeSciences #GenerativeAI #AgenticAI #gfs2025 Remie Abdel Latif, Oliver Stein, Fabienne JAUTARD, Zach Poole, Josh Lambeth, MBA

🎥 Highlights from RAPS Convergence 2025 | 5 Key Takeaways Shaping the Future of Regulatory Affairs RegASK joined regulatory professionals from around the world at Regulatory Affairs Professionals Society (RAPS) Convergence 2025 in Pittsburgh to explore how technology and collaboration are redefining the regulatory landscape. From AI-human collaboration to global convergence, the event highlighted how regulatory affairs is becoming smarter, faster, and more responsible. Watch our video recap to see the 5 key trends driving the future of regulatory excellence. 👉 Stay ahead with AI-driven Regulatory Intelligence. Book a demo with RegASK: https://lnkd.in/dZt2KkiB #RAPSConvergence2025 #RegASK #RegulatoryIntelligence #AiinRegulatoryAffairs #RegTech #RegulatoryInnovation #GenerativeAI #AgenticAI #LifeSciences #Compliance   Kelli Madden, Deanna Coscia, Caroline Shleifer, Remie Abdel Latif, Amenallah Reghimi, Oliver Stein, Zach Poole, Josh Lambeth, MBA, Fabienne JAUTARD

🔍 Event Highlight | RAPS Chapter Atlanta 2025: CTRL + ALT + REGULATE   RegASK is proud to be speaking at the upcoming RAPS Atlanta Chapter In-Person Event: CTRL + ALT + REGULATE, which brings together regulatory professionals and industry leaders to explore how AI is redefining regulatory affairs.   Our Senior Regulatory Intelligence Manager, Kelli Madden, will take the stage to discuss the cautions and watchouts when using AI in RAQ, sharing practical insights on the risks, limitations, and best practices for responsible AI use in regulatory affairs.   The RegASK team will also be on-site engaging with attendees to showcase how our new Vertical Agentic AI Command Center, the Action Hub, helps regulatory teams keep pace with accelerating global change, automate routine tasks, and make faster, data-driven decisions.    We look forward to connecting with fellow regulatory leaders in Atlanta!   📅 Book a one-to-one session with our team: https://lnkd.in/eRrUf8Fz   #RegTech #RegulatoryIntelligence #RegASK #AiinRegulatoryAffairs #GenAI #GenerativeAI #RegulatoryInnovation #RAPS #RAPSAtlanta #RegulatoryAffairs #LifeSciences #Compliance #AgenticAI Deanna Coscia, Kelli Madden, Caroline Shleifer, Amenallah Reghimi, Remie Abdel Latif, Oliver Stein, Zach Poole, Josh Lambeth, MBA, Fabienne JAUTARD

🚀 Press Release | RegASK Launches the First Vertical Agentic AI Command Center for Regulatory Affairs   RegASK has unveiled the Action Hub, the industry’s first vertical agentic AI command center purpose-built for regulatory affairs.   The new Action Hub brings together RegASK’s agent network and AI workflows into a single workspace, simplifying how regulatory teams keep pace with accelerating global change, automate routine tasks, and make faster, data-driven decisions.   The launch also introduces AI-assisted impact analysis powered by RegASK’s proprietary Context Engineering technology and advanced customizations that let users configure the platform to match their unique products, markets, and compliance needs.   Together, these capabilities redefine regulatory intelligence and workflow orchestration, elevating regulatory affairs from a reactive compliance function to a strategic business enabler.   👉 Read the full announcement: https://lnkd.in/geiVu7gQ   #RegTech #RegASK #RegulatoryIntelligence #AiinRegulatoryAffairs #GenerativeAI #AgenticAI #RegulatoryInnovation #Compliance #LifeSciences   Caroline Shleifer, Amenallah Reghimi, Remie Abdel Latif, Ravinder Singh, Rohit Gulati, Rizza Mendoza, Deanna Coscia, Oliver Stein, Josh Lambeth, MBA Zach Poole, Fabienne JAUTARD

🔍 Regulatory News | FSA Proposes Ban on BPA and Related Compounds in Food Packaging   The UK Food Standards Agency (FSA) has launched a public consultation proposing a ban on bisphenol A (BPA), other bisphenols, and bisphenol derivatives in food-contact materials across England, Wales, and Northern Ireland.   Open until 24 December 2025, the proposal seeks to strengthen consumer safety by addressing health risks linked to BPA exposure in packaging and processing materials.   Stakeholders, including food manufacturers, retailers, importers, and scientific experts, are encouraged to provide evidence-based feedback on implementation feasibility, potential exemptions, and alternative materials.   👉 Read the full update: https://lnkd.in/gAKba-9r   👉 Stay ahead with AI-driven Regulatory Intelligence. Book a demo with RegASK: https://lnkd.in/dZt2KkiB   #RegTech #RegASK #RegulatoryIntelligence #AiinRegulatoryAffairs #GenAI #GenerativeAI #RegulatoryInnovation #Compliance #LifeSciences #FoodAndNutrition   Anum Mukhtar, Kelli Madden, Remie Abdel Latif, Deanna Coscia, Oliver Stein, Josh Lambeth, MBA, Zach Poole, Fabienne JAUTARD

“AI isn’t here to replace regulatory affairs teams, it’s here to augment them.” That was the message our Founder & CEO Caroline Shleifer shared when Elena Kyria stopped by the RegASK booth at RAPS for an interview. Rather than fearing it, Caroline highlighted how AI is becoming an enabler, taking on repetitive, time-consuming tasks so regulatory professionals can focus on the high-value, strategic work that drives real business impact. The key is to embrace it and truly understand how it works. A big thank you to Elena for the thoughtful conversation on how AI is reshaping regulatory affairs. It’s through dialogues like these that real innovation is sparked. #RegulatoryAffairs #RegTech #RegulatoryIntelligence #AiinRegulatoryAffairs #RegulatoryInnovation #LifeSciences #RegASK #GenerativeAI #AgenticAI Deanna Coscia, Kelli Madden, Josh Lambeth, MBA, Amenallah Reghimi, Remie Abdel Latif, Ravinder Singh, Zach Poole

🎉 RAPS Convergence 2025 has come to a close!   It’s been an incredible three days in Pittsburgh at the world’s largest gathering of regulatory affairs professionals, connecting with innovators and thought leaders shaping the future of compliance and regulatory intelligence in healthcare.   A huge thank you to everyone who visited RegASK at Booth #843, joined our live demos, and took part in our AirPods giveaway. Big appreciation as well to the Regulatory Affairs Professionals Society (RAPS) team for hosting such a meaningful event that continues to unite the global regulatory community.   As the industry continues to evolve, RegASK remains committed to empowering regulatory teams with AI-driven intelligence that transforms how they manage change, achieve compliance faster, and innovate with confidence.   Here’s to continuing to push the boundaries of regulatory excellence together.   #RAPSConvergence2025 #RegulatoryAffairs #RegTech #RegulatoryIntelligence #AiinRegulatoryAffairs #RegulatoryInnovation #LifeSciences #RegASK #GenerativeAI #AgenticAI   Deanna Coscia, Kelli Madden, Josh Lambeth, MBA, Caroline Shleifer, Amenallah Reghimi, Remie Abdel Latif, Ravinder Singh, Oliver Stein, Zach Poole, Fabienne JAUTARD

🔍 Regulatory News | Global Regulators Confirm No Link Between Paracetamol Use in Pregnancy and Autism in Children Between 23–26 September 2025, health authorities from Singapore (HSA), Australia (TGA), France (ANSM), Switzerland (Swissmedic), Portugal (Infarmed), Spain (AEMPS), Belgium (AFMPS/EMA), Thailand (FDA) and New Zealand (MOH / Medsafe) issued coordinated advisories confirming that current scientific evidence does not support any causal link between paracetamol (acetaminophen) use during pregnancy and neurodevelopmental disorders such as ASD or ADHD. Paracetamol remains the recommended first-line treatment for managing pain and fever in pregnancy when used as directed, with regulators continuing active pharmacovigilance to monitor emerging data. 👉 Read the full update: https://lnkd.in/gBSzdSZY 👉 Stay ahead with AI-driven Regulatory Intelligence, book a demo with RegASK: https://hubs.la/Q03MJnKG0 #RegTech #RegASK #RegulatoryIntelligence #AiinRegulatoryAffairs #GenAI #GenerativeAI #RegulatoryInnovation #Compliance #LifeSciences Anum Mukhtar Kelli Madden Remie Abdel Latif, Khushi Gupta, Oliver Stein, Zach Poole

🌟 RegASK at Matsumoto Trading Academic Forum 2025   Honoured to be featured by Matsumnoto Trading Co., ltd as a key regulatory intelligence partner at the Matsumoto Trading Academic Forum 2025 in Japan.   The forum brought together leading experts and industry partners to explore the latest in cosmetic safety testing, biotechnology-driven innovation, and regulatory management, sparking meaningful dialogue and collaboration across the industry.   As part of the event, we shared how RegASK helps companies streamline compliance workflows, strengthen safety data management, and stay ahead of evolving global regulations, showcasing the power of AI-driven regulatory intelligence in transforming compliance practices.   A big thank you to Matsumnoto Trading Co., ltd for the trust and collaboration. We look forward to our continued partnership and advancing regulatory excellence together.   👉 Stay ahead with AI-driven Regulatory Intelligence. Book a demo with RegASK: https://lnkd.in/dZt2KkiB #RegTech #RegulatoryIntelligence #RegASK #AiinRegulatoryAffairs #GenAI #GenerativeAI #RegulatoryInnovation Ravinder Singh, Natsumi Yamada, Arno Anton, Deanna Coscia, Oliver Stein, Zach Poole, Josh Lambeth, MBA, Fabienne JAUTARD