current landscape & challenges
Regulatory Intelligence tends to be a decentralized and siloed function, with market, scientific, Regulatory authority and regional insights all residing in individual emails, distributed word documents, newsletters and many other sources. In addition to this, Regulatory Intelligence has often been approached as a reactive process, or as an after-thought and has been plagued by limited budgets within Regulatory departments.
In today's fast-moving and ever-changing market, real-time and actionable intelligence is needed to quickly make Regulatory and business decisions.
Regulatory teams also need to widen their search. Internal sources of data, clinical, drug safety and real-world evidence as well as health authority interactions records, all offer a source of intelligence that needs to be mined. And considering much of this data can be unstructured as well as structured, the search, curation, and management are even more challenging.
Freyr's Regulatory intelligence platform, IMPACT, has been designed with several innovations to help deliver real-world, actionable global Regulatory Intelligence from a barrage of diverse external and internal sources. It is based on our experience in BioPharma, MedTech and Consumer Healthcare Regulatory support.
We have developed Robotic Process Automation (RPA) bots and combined these with Natural Language Processing (NLP) engines to search thousands of online sources, 24 x 7. IMPACT will then auto-curate and even summarize the intelligence into specific, consumable information ready to help in decision support. Auto translation is available in 80+ languages.
RPA and NLP also assimilate information from a vast array of internal data sources that include past eCTD submission documents, agency correspondence, Word, Excel, and PDF documents.
Once the data has been pulled together, IMPACT will automatically deliver relevant information to whichever team or individual needs it. We have programmed push/pull functionality with the highest levels of granularity and applicability so that your Regulatory team, or other executive consumers, get the information they need, quickly.