Skip to main content
Skip to footer

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 solutions.

 

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

compliance
100%

compliance to regulatory timelines

timeline
98%

adherence to quality and submission

accountability
100%

accountability of submissions

savings
50%

savings in program management

reporting efforts
40%

reduction in monthly reporting efforts

timely submission
20%

reduction in Health Authority (HA) submission delays

Swipe Right
Swipe Left
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 Regulatory wins the 2021 India Pharma award

TCS ADD Regulatory wins the 2021 India Pharma award

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

contact-icon Contact us Contact us