TEDREG - A Global Regulatory Intelligence Platform

Consolidated | Validated | On-Demand

TEDREG - A Global Regulatory Intelligence Platform

TEDREG - A Global Regulatory Intelligence Platform

Consolidated | Validated | On-Demand

Trending

Trending

Pharmaceuticals, biotech, and medical device manufacturers spend millions of dollars annually in compliance costs across regulated and semi-regulated markets.

With the evolving regulatory landscape and increasing competition and cost pressure, organizations are transforming their status quo to build sustainable business processes relevant to the current times. Regulatory intelligence technology is invariably helping manufacturers to address complex compliance requirements. Moreover, this technology is enabling companies to build an agile and proactive regulatory function capable of anticipating and responding to changes across the value chain.

Trending
Opportunities & Challenges

Opportunities & Challenges

Opportunities & Challenges

Embedding automated regulatory intelligence into the process value chain can help manufacturers address the dynamic regulatory developments across the globe and control OpEx on compliance.

Manual monitoring of regulations is a resource-intensive practice that adds to the company’s operational cost. Businesses are adopting automated methods to monitor and analyze multiple sources for regulatory requirements across the target regions and derive data-driven insights for portfolio strategy. Proactive regulatory intelligence allows manufacturers to disseminate information that can potentially influence future regulatory programs for an accelerated new product launch.

Product Framework

TEDREG - A Global Regulatory Intelligence Platform
Features
  • Meticulous and regular monitoring of local, regional and global regulatory information or updates

  • Literature search and quick referencing when creating aggregate reporting

  • Rule-based automated update alerts and notifications for competitor labels/indications of interest

  • Insights on drug-drug interactions for monitoring compounds

  • Tracking competitor products across therapeutic classes 

  • On-premise or cloud-based deployment

  • The flexibility of search strings to track specific events

  • Ready-to-use information on country-specific and regional compliance requirements

Differentiators

  • Validated insights – Curated intelligence validated by in-house/ external regulatory experts

  • Flexibility for “on-demand” or “periodic & structured” reports

  • On-demand consulting with regulatory experts

  • Commercial models configured for subscription-based, demand-based, and functional service outsourcing

Benefits to the Customer

  • Auto-crawling reduces manual search efforts by 90%

  • Assimilation of data in one single repository reduces information distribution cost by more than 70%

  • Real-time information availability ensure speed of process that impact time-to-market by more than 20%

  • Reduced localization expense can save OpEX cost by 40%

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