Srini Sadhu

Chandrachur Datta, Sr. Partner at Vector Consulting Group, has been featured in Pharmabiz by Nandita Vijayasimha, highlighting a pivotal shift in the Indian pharmaceutical industry. Moving from 'Inspection Readiness' to 'Perpetual Regulatory Readiness,' Datta sheds light on the necessity for Indian pharma companies to adopt a culture of continuous quality management. This approach is critical as the industry confronts stringent US FDA safety and quality regulations. By implementing rigorous root cause analysis and minimizing quality incidents, Indian pharma is poised to achieve the highest standards, aiming for minimal QMS events monthly. The emphasis on reducing analyst capacity wastage and increasing operational efficiency in manufacturing also prepares the sector for highly regulated markets like the US. Read the full article https://lnkd.in/d4sNbKMU to foster a global standard in pharmaceutical excellence. #Pharmaceuticals #QualityManagement #PharmaIndustry #USFDA #QualityAssurance #RegulatoryCompliance #OperationalExcellence #DestressToDeliver #ManagementConsulting #Innovation

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Navigating Complex Pharma M&A: A Growthally Case Study (Year - 2014) Challenge: A leading Indian Contract Research Outsourcing (CRO) company sought a strategic buyer to expand its reach and capabilities. Solution: Growthally Advisors was the sell-side advisor in this process. We were responsible for successfully executing the deal from origin to finalisation. Results: Successful Acquisition: A US-based research-oriented pharmaceutical company acquired the Indian CRO for Rs 30 crores. Acquirer Benefits: ● Access to experienced clinical trial faculty. ● Cost-effective, high-quality research services. ● Entry into the Indian CRO market. Expertise Highlights: ● Sell-side deal origination and transaction structuring. ● Facilitating cross-border transactions. ● Maximising value for CROs seeking strategic partners. Looking for strategic M&A guidance in the pharma sector? Contact Growthally Advisors at https://lnkd.in/dwWHCsqc to explore how we can help you achieve your growth goals. - - - #pharma #M&A #pharmaceuticalindustry #growthstrategy #research #india #GrowthallyAdvisors

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નમસ્તે! US Biosecure Act sparks golden era for Indian Pharma Industry! This game-changing legislation is reshaping the landscape, shifting focus from Chinese biotech and unlocking unprecedented opportunities for Indian #CROs and #CDMOs in the US market. As America diversifies its pharma supply chain, Indian companies are poised to capture significant market share, with project requests and collaborations already surging. This seismic shift is not just reshaping our industry—it's fueling innovation and propelling India towards global pharmaceutical leadership This isn't just a win for Indian pharma; it's our chance to cement our position as a global pharmaceutical supply chain leader. 🤝 Indian pharma powerhouse eyeing US expansion? Join Namaste Global #PharmaCommunity or reach out to [email protected]. Let's innovate together! 🌍💊 #IndianPharma #PharmaceuticalIndustry #BiosecureACT #CRO #CDMO #HealthcareInnovation #SupplyChainResilience #MakeInIndiaForGlobalsilience #MakeInIndiaForGlobal

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🔴#AvendusDealAlert: Delighted to partner with Maiva Pharma Private Limited (FDA Approved Sterile Injectables), India’s 2nd largest pure play injectables Contract Development and Manufacturing Organization (CDMO) for North America, on its INR ~1,000 crores fundraise from Morgan Stanley Private Equity Asia and India Life Sciences Fund. We continue to see strong sponsor interest in India’s healthcare sector, particularly in the CDMO theme, as India is becoming a major outsourcing hub for pharmaceutical manufacturing and research related services. Learn more: https://bit.ly/3weqPtz Bhaskar Krishna Arumugam I Shivananda Hegde | JACKSON SILVA I Nirav Mehta I Vaibhav Bagri I Madhav Bhatnagar | Parv Chadha I Sumit Gupta I Paritosh Nayak I Ashwini Mogilisetty Anshul Gupta I Pushkaraj Dhake I Sanyam Chhangani I Shivam Rajoriya #PrivateEquity #Fundraise #Injectables #Pharmaceutical #Pharma #Healthcare #InvestmentBanking #NextIsTheOnlyLevel

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The biotech business Transcell Biologics Private Limited, which specializes in stem cell technology, has received funding from IAN Group (formerly Indian Angel Network) and Boston-based Quantiphi. With the help of the additional capital, the company plans to grow its clientele and introduce Digital Animal Replacement Technology (DART), an enterprise-wide solution for the bio and pharmaceutical sectors. DART provides animal-free medication and vaccine testing methodologies, optimizing bioassay procedures and guaranteeing safety and efficacy. It does this by fusing human Micro Physiological Systems (hMPS) technology with artificial intelligence (AI) and machine learning on an in silico platform. Transcell Biologics, which was founded in 2009 by S Dravida, offers patented procedures for stem cell applications and focuses on optimizing stem cell yield while preserving pluripotency and functionality. #TranscellBiologics, #Biotech, #StemCellResearch, #DART, #DigitalAnimalReplacementTechnology, #AI, #MachineLearning, #Pharmaceuticals, #Bioassay, #HumanMicroPhysiologicalSystems, #Innovation, #Biopharmaceuticals, #AnimalFreeTesting #Startuphonor

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We're thrilled to announce Federation of Asian Biotech Associations (FABA) as our Knowledge Partner for the 4th Edition of the India Biopharma Leaders Conclave, proudly presented by M R Sanghavi & Co., powered by Rockwell Automation, and hosted by BlueTech Media™. Together, we're set to embark on a journey to explore "New Horizons in Biopharma, Biosimilars, & Biologics!" 🚀 . Date: 13th & 14th June, 2024, Hyderabad To Register for the event click https://lnkd.in/d2T9iruW . This year's theme promises a deep dive into the latest advancements shaping the biopharmaceutical landscape, with a spotlight on the exciting realms of biosimilars and biologics. With renowned speakers and eminent leaders from around the globe, this event is set to be a beacon of knowledge and innovation. . Why Attend: 🔍 Gain valuable insights into industry evolution, regulatory changes, and compliance challenges. 🤝 Expand your professional network by connecting with industry peers and potential collaborators. 💡 Discover cutting-edge products, services, and technologies driving biopharma innovation. 🔄 Engage in meaningful discussions to shape the future trajectory of the industry. 🔬 Explore challenges and opportunities, from regulatory hurdles to ethical considerations. . Event Highlights: 🎤 40+ Speakers 🤝 200+ Delegates 🤝 4+ Associations 📰 4+ Media Partners 🤝 15+ Partners . Key Topics Include: 🔬 The future and challenges of biosimilars 🔬 Success rates and challenges in biosimilar R&D 🔬 Quality, safety, and efficacy standards in biosimilars 🔬 Future of cell and gene therapy manufacturing 🔬 Emerging trends in quality assurance for biologics 🔬 Digitalized supply chains in biopharma 🔬 The crucial role of a digital backbone in the industry 🔬 Advances and barriers in CAR-T cell therapies Don't miss this opportunity to be at the forefront of biopharmaceutical innovation! . #Bluetechmedia #IndiaBiopharmaLeadersConclave #pharmaevents #pharmaceutical #Corporate #PharmaEvents #PharmaConferences #PharmaConclave #PharmaLeaders #BlueTechMedia #BiopharmaLeaders #Innovation #Biosimilars #Biologics #IndustryInsights

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📣 Exciting Update! 🚀 Don't miss Scott Bradley Novartis and Alok Bhanot's ParkourSC upcoming session at Gartner, where we're unraveling the future of pharmaceutic supply chains. As the Pharmaceutical ecosystem moves towards a greater reliance on specialty medicine, it faces more significant pressure to uplevel its supply chain maturity. Did you know that 91% of CSCOs require the proper technology framework to support event-driven decision-making, while 60% are expected to make faster and more accurate decisions in real-time? 💡 Learn firsthand how Novartis leverages AI/ML-based Decision Intelligence capabilities to build a reliable supply chain with improved patient outcomes. 📅 Mark your calendars: Wednesday, 8th May at 11:30 AM 📍Location: Swan Ballroom 6, WDW Swan Hotel Don't miss out on this opportunity to stay ahead of the curve in the pharmaceutical realm. See you there! #PharmaSupplyChain #Gartner #DecisionIntelligence #GartnerSupply ChainSymposium 🌟

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Our partner Sidharrth Shankar, offers expert insights on cybersecurity in India's pharmaceutical industry in his latest article titled, 'Regulatory measures for cybersecurity in India’s pharmaceutical industry' for Express Pharma. Delving into regulatory measures and practical strategies, Sidharrth addresses the pressing need for heightened cybersecurity in this rapidly evolving sector. https://lnkd.in/ep4UwEBC #artificialintelligence #internetofthings #regulatory #cybersecurity #pharmaceutical #jsa #leadinglawyers #leadinglawfirms

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With the Biosecure Act poised to reshape the global biotech and pharma landscape, India is uniquely positioned to capitalize on this opportunity. As the US shifts away from Chinese suppliers due to national security concerns, India's Contract Development and Manufacturing Organizations (CDMOs) have a chance to take the lead. But with opportunity comes responsibility. For India to truly dominate, our pharma and biotech industries must step up their IP protection and regulatory standards. Here are the key IP challenges India needs to address: 𝑆𝑡𝑟𝑒𝑛𝑔𝑡ℎ𝑒𝑛𝑖𝑛𝑔 𝐼𝑃 𝑓𝑜𝑟 𝑅&𝐷: As Indian firms expand in drug discovery, ensuring robust patent filings and IP protection will be crucial for global competitiveness. 𝑁𝑎𝑣𝑖𝑔𝑎𝑡𝑖𝑛𝑔 𝑅𝑒𝑔𝑢𝑙𝑎𝑡𝑜𝑟𝑦 𝐶𝑜𝑚𝑝𝑙𝑖𝑎𝑛𝑐𝑒: Aligning with U.S. FDA standards and global IP norms is essential to prevent patent or regulatory challenges that could undermine India's reputation. 𝑅𝑒𝑑𝑢𝑐𝑖𝑛𝑔 𝐴𝑃𝐼 𝐷𝑒𝑝𝑒𝑛𝑑𝑒𝑛𝑐𝑦: India needs to innovate and patent new methods of API production to reduce reliance on China and capture more market share. 𝐶𝑟𝑜𝑠𝑠-𝐵𝑜𝑟𝑑𝑒𝑟 𝐼𝑃 𝑆𝑡𝑟𝑎𝑡𝑒𝑔𝑦: With more U.S. partnerships on the horizon, Indian companies must negotiate strong IP agreements to protect their innovations while respecting collaborative ownership. Navigating the complexities of IP protection, regulatory compliance, and cross-border partnerships is key to safeguarding your innovations and staying competitive in this evolving global market. Is your company prepared to tackle the IP challenges ahead? #Boudhik #boudhikIP #ipreview #IPR #Trademark #usbiosecureact #indiaspharma Karan Sharma Vivek Dahiya Ishan Tiwari Kritika Upmanyu Shubham Singh Thakur Amit Singh

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📢 Exciting News! AmpleLogic is proud to be a Silver Sponsor at Federation of Asian Biotech Associations (FABA)! On August 7th at 11 AM, our very own Mr. Manne Venkanna Chowdary will take the virtual stage to discuss "Harnessing Digital Technologies for Enhanced Drug Manufacturing in Pharma." We're thrilled to be part of this insightful session! #AmpleLogic #FABA #DigitalTransformation #PharmaInnovation #IndustryLeadership

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One of the most significant advancements in pharmaceutical #sterilitytesting is the adoption of rapid microbiological methods (RMM). In this blog, get perspective on the market demand for RMMs and the benefits of implementing one into your #qualitycontrol program. #patientsafety https://lnkd.in/edmZErBg

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Turn your pre-IND meeting into a strategic advantage and set the stage for a smooth regulatory journey. Here are essential tips on key discussion points, effective communication strategies, and aligning your development plan with FDA expectations: https://hubs.ly/Q02Cd_0m0 #clinicaltrials #clinicalresearch #drugdevelopment

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Enhancing Patient Engagement in Support and Assistance Programs Vaibhav Tewari, Co-Founder and CEO, Portea, engaged in a conversation with #IndiaPharmaOutlook, discusses how pharmaceutical companies are leveraging digital innovations such as SaaS platforms, AI-powered chatbots, and secure communication tools to address patient accessibility, data privacy, and engagement. Discover More: https://bit.ly/47VPykB #digitalinnovations #dataprivacy #pharmaceuticalsupport #digitalliteracy #digitaltechnologies #pharmaceuticalindustry #AItechnologies

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Discover insights from our latest article by Vijay Varshney, featured in Express Pharma. Titled "The Pharmaceutical Retail Industry: A Paradigm Shift for Growth and Compliance Driven by Data Visibility," this piece explores the critical role of data visibility in the pharmaceutical sector. Learn about the challenges of managing supply chain data and the importance of technologies like centralized data integration, blockchain, AI-driven insights, and standardized data formats. The article also presents strategies to enhance data visibility, a case study on data analytics driving market share growth, and the vital role of technology in decision-making and compliance. #Pharmaceuticals #DataVisibility #PharmaGrowth #Compliance #Innovation #Smollan #ExpressPharma

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Nirmalya Enterprise Platform’s Regulatory Info Management Sstem is designed for Life Sciences Orgs, with features like electronic signatures, watermarks, workflow mgt, doc control, and audit trails. It helps orgs comply with regulations and maintain doc integrity and transparency across product lifecycle. To know more about Nirmalya Enterprise Platform, please contact us today! #NERP #FMS #ANALYTICS #AI #BI #WORKFLOW #RIMS #NIRMALYA Shreeya Mishra

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