Regulatory Intelligence Tools, Regulatory Intelligence Software

Regulatory Intelligence Tools

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 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 with labeling projects

• Robust tracking and reporting mechanism

• Ability to store and archive labeling 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 Company Core Data Sheet (CCDS)

• In-depth and updated understanding of the Regulatory operations in global labeling, for example, 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

• 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