India Pharma Awards 2021
TCS ADD™ Regulatory platform won the India pharma awards 2021
TCS ADD™ Regulatory
Faster and in-compliance drug registration
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- TCS ADD™
- Solution
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.
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Products and Platforms
TCS ADD™
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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.
Related Insights
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.
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07 Aug 2024
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.
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22 Sep 2025
This paper dives into how AI technology is unifying fragmented clinical data to make clinical trials more patient-centric, effective, safer, and efficient.
Article
20 May 2025
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 solutions.
In Focus
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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
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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 LeftSwipe RightThe 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
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