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    • TCS ADD™
    • Solution

    TCS ADD™ Regulatory

    Faster and in-compliance drug registration

    Request for Demo

    Merck transforms its regulatory operations

    Chris Lee, VP, Global Regulatory Affairs and Quality Management, Merck, explains how TCS, through TCS ADD™ Regulatory, is creating solutions beneficial not only to Merck but to the overall industry in terms of accelerating the rollout of new drugs.

    3 MINS WATCH
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    TCS ADD™ Regulatory Brochure (8 pgs)

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    Products and Platforms

    TCS ADD™ This will open an overlay

    TCS ADD™: A Suite of Modern and Open Technology Platforms 

    TCS ADD™  is a suite of modern and open technology platforms for clinical research and drug development that helps make clinical trials more agile and safe. 
    Learn More
     about TCS ADD™: A Suite of Modern and Open Technology Platforms 
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    Related Insights
    TCS Life Sciences Forum 2024 London: Leveraging AI for Clinical R&D and PV
    Join us at the life sciences event to learn how AI and generative AI can accelerate next-gen clinical R&D and enhance patient safety. Register now for the event.
    Events
    07 Aug 2024
    Meet TCS at the World Drug Safety Congress Americas 2024
    Engage with our experts at the World Drug Safety Congress Americas 2024 to learn about AI in pharmacovigilance and our TCS ADD™ Safety platform. Join us now.
    Events
    09 Sep 2024
    TCS Life Sciences Forum 2025 London
    Join the TCS ADD™ forum at Pace Port™ London to explore AI/generative AI in clinical R&D and pharmacovigilance and how it is transforming life sciences.
    Events
    22 Sep 2025

    India Pharma Awards 2021

    TCS ADD™ Regulatory platform won the India pharma awards 2021

    Features

    Monitoring of regulatory processes via real-time alerts

    50% reduction in submission management activities

    Up to 20% reduction in overall regulatory cycle times

    Challenge

    Operational inefficiencies due to the lack of end-to-end traceability, effort-intensive tracking and reporting across projects, and associated plans lead to submission misses and non-compliance.

    Stringent regulatory compliance and submission standards by authorities have increased the risk of non-compliance and higher costs. In most cases, the existing regulatory intelligence platform is devoid of cognitive intelligence. Also, project planning is highly complex in nature and lacks self-intuitiveness.

    Siloed views and gaps in regulatory submission status, lack of visibility and reuse of components, operational inefficiencies, and cumbersome program management have led pharmaceutical organizations to adopt AI/ML-driven technology platforms.

    Download brochure

    In Focus

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    Swipe Right

    Envision Smart Regulatory Intelligence in Pharma

    White Paper | 09 Dec 2022   Opens in new tab

    Unlock future of AI-driven smart pharmacovigilance

    video | 28 Jul 2022   Opens in new tab

    Unlock Transparency of AI Models in PV

    White Paper | 21 Oct 2022   Opens in new tab

    Regulatory overhaul for Merck

    Case Studies | 23 Aug 2022   Opens in new tab

     

    our solutions

    Enables the tracking of integrated and actionable regulatory processes across all operating systems, including mobile apps. The module also provides automated alerts and notifications. In addition, it provisions a rich and easy-to-use reporting dashboard and visualization as well as facilitates a template-driven submission planning and customization that allows precise planning at milestone-task-component level

    Facilitates intelligent redaction, data anonymization, review, quality control (QC), and formatting of regulatory content. The module also facilitates AI-enabled label discrepancy identification and provides region and country-specific archival analytics and reports

    Provides a repository of internal and external regulatory data providing meaningful insights; provisions a smart search engine for Response to Query (RTQ) and market intelligence that comprises a centralized repository of domain ontologies, and accelerates the creation of regulatory responses and submissions

    Integrates and reuses data, documents, and templates from multiple sources through SmartAuthor, thereby automating document creation and reducing submission discrepancies

    Benefits

    Swipe Right
    Swipe Left
    100%

    Compliance to regulatory timelines

    98%

    Adherence to quality and submission

    100%

    Accountability of submissions

    50%

    Savings in program management

    40%

    Reduction in monthly reporting efforts

    20%

    Reduction in Health Authority (HA) submission delays

    Swipe Left
    Swipe Right

    The pandemic resulted in unprecedented collaboration and agility across the pharma ecosystem. With rapid and safe roll-out of drugs of utmost importance, pharma organizations world-over are harnessing the power of AI and analytics to accelerate the regulatory submission process and launch new drugs for patients.

    Rachna Malik

    Global Head, TCS ADD™ Platforms

    RECOGNITION

    TCS ADD™ wins India Pharma Awards in 2019, 2021, 2022, 2023, and 2024

    TCS ADD™ wins India Pharma Awards in 2019, 2021, 2022, 2023, and 2024

    TCS ADD™ Safety wins the 2020-21 Awards.AI for using AI to re-imagine pharmacovigilance

    TCS ADD™ Safety wins the 2020-21 Awards.AI for using AI to re-imagine pharmacovigilance

    TCS ADD™ Connected Clinical Trials platform wins the 2020 Citeline Award

    TCS ADD™ Connected Clinical Trials platform wins the 2020 Citeline Award

    TCS' ADD™ Connected Clinical Trials platform wins the European Innovations Award

    TCS' ADD™ Connected Clinical Trials platform wins the European Innovations Award

    Transformation starts here

    Learn how we can help you bring drugs to the market faster.

    Request for Demo

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