Overview

Freyr INSIGHT is Freyr’s Regulatory Intelligence Enterprise Platform, which gathers and analyzes publicly available regulatory information. This includes communicating the worldwide reach of regulations, pharmaceutical updates using a system, and monitoring the current regulations, guidance, policy, and legislation.

 

Freyr INSIGHT Capabilities

Solution Highlights

  • On-Demand Simple, Cost Effective Licensing Model
  • Web based tracking tool with simple UI
  • Unique inbox enabled forum to track and contribute to discussions and issues with labelling projects
  • Robust tracking and reporting mechanism
  • Ability to store and archive labelling info and supporting documents
  • Milestone tracking feature also
  • Assured Data security
  • Minimal Setup
  • Audit Trail & Record management
  • Services on developing the tools for tracking and maintaining the database/repository of products
  • Highly qualified medical experts, with extensive experience across diverse Healthcare and Life Sciences domains for reviewing and suggesting the changes to the CCDS
  • In-depth and updated understanding of the regulatory operations in global labeling e.g. submission of the Label change to the local regulatory authority bodies

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
  • Assesse likelihood of success
  • Health Authority 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 Information
  • Regulatory News Sources & Databases
  • Upcoming regulations related discussions/updates through Congress Coverage/Trade Associations
  • Laws, Regulations, Guidance
  • Advisory Meetings
  • Approvals
  • Health Authority alerts and websites
  • Ad Hoc Health Authority Queries
  • Regulatory News
  • Regulatory Databases
 

Freyr INSIGHT Features

  • Global Dashboard
  • Track updates using
    • Therapeutic area
    • Product category
    • Active ingredients
    • Excipients
  • Information category
  • R&D
  • Manufacturing
  • Quality
  • Export/Import
  • Distribution
  • Pricing
  • Over 25 categories
  • Easily share across departments, across geography
  • Assign actions, track progress
  • Discuss, collaborate and share on new updates
  • Email Alerts

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

Request a Demo
 

Driving Superior Market and Regulatory Submission Strategies

Freyr Regulatory Intelligence solution enables companies and regulatory professionals to quickly and effectively meet their critical information requirements while saving on time. Download
 

Regulatory Intelligence CoE

A cloud-based Regulatory Intelligence software solution offering regulatory insight from authoritative sources in real-time along with 400+ virtually distributed regulatory experts keeping abreast with ever-changing global regulatory environment, Freyr offers companies the best of both worlds – on-demand regulatory intelligence software solution as well as a Centre of Excellence that offers best in class, cost-effective and customizable regulatory intelligence outsourcing services model built around clients’ unique and demanding requirements.

Click on below button to know more about  Regulatory Intelligence Services CoE

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CLIENT TESTIMONIALS

 
  • I approached Freyr with an issue we were having in quickly confirming the global acceptability of several new raw materials for use in our products. Within a few days, their team provided me with a comprehensive review by country citing regulatory references. The reports also included valuable additional information regarding cosmetic uses of the materials in various markets. For a very reasonable price, Freyr was able to provide our company with exactly what we were looking for.

    – Director, Regulatory Affairs, US based, Cosmetics Manufacturing Company

  • Freyr provided assistance and the review was conducted thoroughly and rapidly. I also appreciate that the team called me this morning and walk me through the files. It is once again a pleasure working with Freyr.

    Just wanted to say that the team are doing a great job. Please keep up the excellent work!

    – Product Specialist Global Regulatory Affairs, Global Top 5 Healthcare Company