Freyr leads the establishment of a new Regulatory Intelligence function within a Large Size Innovator Pharmaceutical Entity through Bespoke Staffing solution and Consultancy services

Business Imperatives

An EU-based multinational innovator pharmaceutical company was having difficulties staying up to date with relevant and time-critical Regulatory information coming from multiple sources and geographies despite having a solid Regulatory Affairs team.
Internal services and tools were not adequate for accelerated & holistic decision-making.
As a result, the company was taking a reactive approach for their global brands leading to a risk of the brands being adversely affected in the global markets due to Regulatory non-compliance.

To help an EU based multinational pharmaceutical company increase process efficiency in Regulatory intelligence and decrease people and technology costs while maintaining compliance with a robust Regulatory intelligence platform.

Deluge of information from existing multiple tools yet lack of relevant, actionable intelligence
Lack of clearly defined processes to manage relevant global RI data
Non-harmonized data categorization across multiple tools
Integrate downstream and upstream processes and data with a centralized Regulatory Intelligence eco system.
Limited inhouse resources in RI team to centralize and manage the data
High cross-functional dependency with no defined roles and responsibilities

5 step RI consulting approach; Understanding the existing Regulatory setup, Gap Analysis of the current approach towards people, process and technology, Proposing a holistic scheme for efficient RI operations, Validation of the plan and implementation
Proposed plan for a centralized, harmonized RI process and data management platform
Significantly reduced compliance costs via lowered dependence on multiple tools and cross-functional teams