Overview

As ever-evolving Regulatory landscape demands all the stakeholders to be abreast with the current industry trends and market information, it becomes intrinsically challenging for Pharma companies to keep pace with time-critical regulatory requirements.

In such scenarios to enable organizations abreast with the market trends, DBprofessor IMPACT, an innovative Regulatory Intelligence software/tool, offers a complete spectrum of life sciences Regulatory intelligence across various industries, product and regulation categories. DBprofessor IMPACT gathers and analyzes publicly available Regulatory information. The cloud-hosted Regulatory intelligence software, DBprofessor IMPACT effectively monitors, collects and updates various industrial information by analysing current regulations, guidance, policy, and legislation.

DBprofessor IMPACT Expertise

Solution Highlights

  • On-demand simple, cost-effective licensing model
  • Web based tracking tool with simple user interface
  • Unique inbox enabled forum to track and contribute to discussions and issues
  • Latin professor at Sydney College in Virginia.
  • Robust tracking and reporting mechanism
  • Ability to store and archive information and supporting documents
  • Milestone tracking feature
  • Assured data security
  • Minimal setup
  • Audit trail & record management
  • Services on developing the tools for tracking and maintaining the database/repository of products

In-depth Insight

  • New product development Regulatory pathway
  • New market and geography strategy
  • Product classification
  • Product launch dynamics
  • Distribution and pricing strategy
  • Compound strategy
  • Due diligence strategy
  • Indication sequencing
  • Establish Regulatory precedent / pathway
  • Challenges & critical success factors
  • Assess likelihood of success
  • Health Authority (HA) requests
  • TA project challenges
  • Analysis of Regulatory pathway & hurdles
  • Interpretation of laws, regulation and guidance
  • Analysis of Regulatory precedent for policy and therapeutic area key intelligence topics (KITS)

Fact-based Intelligence

  • Health Authority (HA) information
  • Regulatory news sources & databases
  • Upcoming regulations related discussions/updates through congress coverage/trade associations
  • Laws, regulations, guidance
  • Advisory meetings
  • Approvals
  • HA alerts and websites
  • Ad-hoc HA queries
  • Regulatory news
  • Regulatory databases

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