Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their presence in the market. Regulatory compliance and authorizations being the key factors behind any winning launch, inadequate Regulatory information can trigger an increase in costs and time-to-market.

With well-managed compliance data management, the Life Sciences industry can handle initial risk, but it is required to be governed continuously with evolving regulations. A comprehensive Regulatory Intelligence (RI) role by harnessing the power of data is an apt approach for your future business decisions.

Current Challenges in the Industry

Regulatory Intelligence offers strategic excellence to address current challenges in the industry, such as unstructured free text, inconsistent data quality, inefficient processes, constantly growing data volume, multiple translations, and information sources.

With the change in the world and so much emphasis on data, it is becoming essential for Regulatory based organizations to focus on monitoring data intelligence and analzsing any product in detail.

Regulatory Intelligence Competency Maturity (RICM) helps in measuring the competency of RI in the current scenario. Let us look at some of the Regulatory Intelligence competence parameters:

S- Small companies M-Mid-Size companies L- Large Companies

1. Data Collection: Data Collection is often manual in small-medium level companies with slight evolution in large companies. There is no specific benchmarking on data quality, and the content is often not curated & limited to key products/markets. For large organizations currently lying in the evolving stage, there are certain bot-driven data scraping defining the QC process.
2. Data Repository: Data repository is properly maintained for medium and large organizations. However, for small companies, no single repository exists. For small organizations, the data repository is maintained in regular spreadsheets or local databases, and for medium and large, it is managed in a centralized spreadsheet with a limited key to markets and health authority-issued regulations.
3. Data Monitoring: Data monitoring is often passive and asynchronous in small-size companies, whereas there is some level of automation in medium and large-size companies. The frequency of data monitoring is set to pre-set rules and is initiated by internal teams manually.
4. Upstream & Downstream Integration: Most of the product’s information in the small, medium, and large size Life Science companies exists in standalone systems. Access to integrated information is often manual and time-consuming.
5. Data-driven Decision-making: In all industries, current capability lies in decision-making capability for basic data translation, often ‘limited due to the lack of integrated information available. Dashboarding & visualization of key information are often manual for small, medium, and large organizations.

For systematic data collection, monitoring, and data-driven decisions, automation with AI/ML is required to be integrated within the system. Integration of Regulatory Intelligence solutions is required for holistic decision-making, and the great promise of RI in technology and life sciences brings modernization with the improvement of relevant data.

The key results of RI in the Regulatory industry lie in timely submissions, efficient approval, better decision-making for turnaround time, compliance, and proactive marketing strategy. Freyr enables the Regulatory industry to adhere to the HA regulations and leverage data by accelerating advancement through interactive dashboards and reports. Freyr IMPACT – an in-house Regulatory Intelligence platform infused with automation and machine learning, bringing innovation in Regulatory world with hidden insights into data and advanced intelligent solutions

To know more about how Freyr IMPACT can accelerate intelligence-driven decisions in your business, contact our digital transformation experts.