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, Freyr IMPACT, an innovative Regulatory Intelligence software/tool, offers a complete spectrum of life sciences Regulatory intelligence across various industries, product and regulation categories. Freyr IMPACT gathers and analyzes publicly available Regulatory information. The cloud-hosted Regulatory intelligence software, Freyr IMPACT effectively monitors, collects and updates various industrial information by analysing current regulations, guidance, policy, and legislation.

 

Freyr 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
  • 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
 

Freyr IMPACT Features

  • Global dashboard
  • Track updates using
    • Therapeutic area
    • Product category
    • Active ingredients
    • Excipients
  • Information category
    • R&D
    • Manufacturing
    • Quality
    • Export/Import
    • Distribution
    • Pricing
    • Supports over 25 categories
  • Shareable platform across departments and geographies
  • Regulatory reporting software
  • Assign actions, discuss, collaborate and share information on new updates
  • Regulatory tracking software

To Know More about Freyr IMPACT and to take a feature-specific comprehensive product tour.

Get a Quote / Request a Demo
 

Freyr Service

Keeping abreast of the ever-changing Regulatory environment, Freyr enables Lifesciences organizations take informed decisions to create superior market strategies. With a comprehensive understanding of the industry, and having global presence across 120+ countries, Freyr helps organizations right from decoding Regulatory pathways to providing regional Regulatory intelligence to successfully defining strategies for various health authority submissions and market approvals. In simple terms, Freyr enable organizations access the global markets with impeccable Regulatory strategies. 

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