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Freyr IMPACT - Innovative Cloud-hosted Regulatory Intelligence Software/Tool
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.
- 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
- 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)
- 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
- 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