Hi. Hi. I am Satish Gola. I bring over 17 years of IT experience with nine plus years deeply focused on Vow vault implementations across both commercial and r and d in the lifecycle life sciences industry. I have led global rollouts, legacy migrations and automation initiatives that streamlined operations for top pharma clients like Bristol and Mayor. BMS and Pfizer. Today I'm here to walk you through how platform thinking combined with AI and structured content is fundamentally changing the way regulated submissions are delivered, especially in high stake areas like rare diseases. So let's dive in. Let's start with a problem on an average bringing a therapy to market, which takes around several years, especially more like 10 years, and shockingly, 40% of the time is spent on managing documentation, but not innovation. So every day of delay means we are losing close to one to 3 million every day. And more importantly, patients are waiting and a single clinical document has to go through six to eight review cycles and abortion conflicts, or which are like constant pain point, these inefficiencies at months and sometimes years to the entire process. Why the traditional approaches fail. Today's regulatory and content process are slowed down by paperwork, disconnected systems, and lack of coordinations. Teams in clinical, regulatory and commercial areas often work in an isolation, leading miscommunication and repeated works. Even a small content change can trigger full re-approval cycles, and within each country demand. It has different localized documents, things getting harder and harder. Day by day, but there is a better way. How can we make this better? By connecting the platforms that unify teams and tools and reusable content blocks that adopt to different markets without starting from sketch, and then automated workflows that reduce back and forth, speed up and approvals. The opportunity is very clear. We need to engineer efficiency. By moving static documents to structured content platforms, we gain a massive speed. This think reusable building blocks, workflow automations, and global scalability. This is not digitalization. It's about transforming the way the life sciences work. Modern platforms like we all are leading this transformation. Contents content as component means documentation can be reused across markets. Workflow automations allows for parallel reviews and. Fast track approvals and the integration layer connects clinical, regulatory safety and commercial functions which is breaking many barriers. What's the result? It's like faster, more compliment, compliant like it, it makes more the submissions more compliant. Let's talk about key technologies driving this transformation. A powered quality checks, which spots errors before they become any bottlenecks. Cloud native collaboration allows global teams to work on the same content in real time, and by integrating real world data, documents can evolve dynamically as outcomes or any safety data changes. So all these technologies, they bring both speed and precision during a global health emergency, which usually takes six months, a regulatory submission was just completed in eight days. Can you believe this? How? Of pre-approved templates and then parallel approval parallel workflow workflows across 22 agencies, real-time collaboration and automated localization. What's the end result? Patients got an access to the treatment five months sooner. Which usually takes six months. It was completed in eight days. We have a, another case study for global launch efficiency. A mid-sized biopharma had a challenge. Launching it in 18 markets within a small regulatory team. With platform-based authoring, reusable submission components and automated translations, the acute simultaneous launches cutting the localization timelines by 40%. This is the impact, which is now becoming the norm. Let's measure the business impact. Let's look at the numbers. So it's gonna be 50% faster document lifecycles through smarter workflows. And then 40% of localization, which enables multiple markets at once and 80, 85% fewer safety findings, which improves the complaints and how, you know how much it's gonna save. It's gonna save close to 2.5 million per therapy and per day. These are not just stats. These this is a real ROI. So what's next? It's a, it's the future. AI and regulatory intelligence is gonna be the future. A will power predictive regulatory analysis. It's gonna scan thousands of submissions to guide strategy and it's gonna automatically draft any structured data, which is gonna save 60% of the authoring time, and it's gonna perform the dynamic risk assessments as well, adopting to changing the regulations in real time. So a is gonna transform the regulatory completely from reactive to proactive. So next we are gonna discuss about how these rare disease approvals can be accelerated. Rare diseases, right? Which needs a speed. With the platforms, what we have now it's gonna be adaptive trial documents that, that update as patient data changes. And then patient reported outcomes integrated directly and real time core reviews with the agencies. So these advances are helping reduce approval time by almost eight 28%. Getting critical therapies to to those who need the more, let's look at the implementation roadmap. This here is how to get started. We have to do an assessment, understand your current pain points, and then foundation building set up your platform and set up the governance, and then process integration, connect clinical studies, safety and regulatory systems. And then we ought to do a scaling, expand across the teams and bring in an AA. Quick wins come early, and scalability ensures long-term success. Let's look at the change management consideration. This is not just tech, right? It's just a cultural shift. Others become content engineers, and then teams must learn the structured authoring and the new workflows. We all know that change is hard, but with the, with all the executive support that we have, it's gonna, it's, we are gonna manage it. It becomes very pretty manageable. And then remember, this is not just admin work, it's a strategic content engineering, which fuels a lot of innovation. What are the key takeaways? Let's recap the four key ideas. Time is lives every day, saved to help patients, and then platform thinking, which drives scale and speed. Global by design launch in all markets very faster, in a quicker way. And then a exhilaration turns bottlenecks into breakthroughs. The companies that master these will lead to the next wave in life senses. So what you can do next, you can benchmark your current document cycle times, identify reuse opportunities, map your existing tech stack. Start with high value areas. Evaluate platforms like OW, vault and Plan a phase rollout every day. We save in regulatory means, getting life changing, treat. Every day we save in regulatory, which means getting a life changing treatments to patients in a much, much faster way. And I would like to thank you for providing this opportunity. I really appreciate your support and I got a chance to represent this innovative. So thanks everyone and I really appreciate your support.