GlobalData Plc

Regulatory Milestones Tracker

GlobalData’s Regulatory Milestones Tracker solution provides an interactive, comprehensive and analytical view of Product Expiry and Exclusivity Type for Marketed Products in the 7 Major Markets (US, Japan and the EU5). In addition, the Regulatory Milestones Tracker tracks important Regulatory Designations such as Orphan Drug Designation, several Accelerated Pathways, and the Prescription Drug User Fee Act (PDUFA) date.

Our Regulatory Intelligence involves Key Patent Analysis and Constraining Patent Identification to establish an estimated Product Expiry date. This information is delivered via a user-friendly and interactive solution that provides flexible data output options to view Product Expiry alongside Review Designation information.

A wide range of sources is used for Product Expiry updates such as the United States Food and Drug Administration (USFDA) the Orange and Purple Books, News, financial filings, investor relations, public relations and Patent Registries. Regulatory Designations are sourced from News and Regulatory sources.

Why Choose Our Regulatory Milestones Tracker?

The Regulatory Milestones Tracker allows you to access Regulatory Intelligence and Exclusivity information for Marketed Pharmaceutical Products. Furthermore, you can view integrated information from different Databases as well as the ability to analyze Constraining Patent information by other attributes of the Product, including Company, Indication and Regulatory Geography. In addition, this module offers the following benefits:

  • Save time and effort through accumulated Regulatory information from various sources and registries in a standardized comparable format.
  • Standardized information for Patents filed in different jurisdictions and countries.
  • Gain access to a 24/7 ‘Ask an Analyst Support Service’ plus, research support and training.
  • Access data retrieval services at no additional cost.

Who Can Our Regulatory Milestones Tracker Help?

  • Pharmaceutical and Biotechnology Companies
  • Generics Manufacturers
  • Contract Manufacturing Organizations
  • Contract Research Organizations
  • API Manufacturers
  • Service Providers
  • Investment Banks, Venture Capital and Private Equity Firms
  • Consultancies
  • Financial Advisors
  • Universities and Research Institutes
  • Governmental Organizations
  • Strategic Planning
  • Business Development
  • Market Research and Competitive Intelligence
  • Research & Development
  • Marketing
  • Regulatory Affairs