Future Proof your Investments with Freyr - In terms of

Time, Effort, Money

The global Regulatory landscape is getting more complex. Stay one step ahead of the Regulatory changes and optimize your end-to-end Regulatory Data and Information Management Systems. Simply put, Freyr facilitates companies to understand their requirements regarding products, registrations, submissions, correspondence and commitments in one centralized place accessible from anywhere.

Key Highlights

Freyr specializes in providing consultancy services and solutions to the global life sciences industry: Superior Pharma Regulatory Expertise in mission- critical processes.

1. GAP ANALYSIS

  • Findings, Recommendations, Approach for Transformation
  • Identify triggers, processes and workflows across functions
  • Systems repositories, folders and naming conventions
  • Resources, skillsets, location, cross-functional interaction, methodologies, trainings

2. CURRENT STATE ASSESSMENT

  • Transparent Information collection approach
  • Process, technology and information and productivity approach
  • Managements view of risks vs findings with risk management and escalation training and a detailed report on focus areas

3. TRANSFORMATION

  • Region-wise Phased Implementation
  • Phase-wise Detailed Transition Plan
  • Planned resource requirements with a resource model
  • System and infrastructure model with to-be plans and detailed transition approach

4. ROI ANALYSIS

  • Investment Vs. Annual Savings – volume adjustments for optimum ROI
  • Aggregated and market specific ROIs – Internal vs external resources
  • Transition models – optimum and parallel transitions for higher ROI

5. REGULATORY STRATEGY

  • Dedicated Regulatory strategy for each product
  • Market analysis with a predictive forecast
  • Experts in communication with Health Authorities worldwide

6. CENTRALIZATION

  • Reducing redundancy and optimizing processes to increase efficiency
  • Multiple roll out scenarios
  • Data migration plans
  • Role-based training programs

Key Benefits

  • Qualified Experts with extensive knowledge of Regulatory guidelines and directives
  • Insights that help clients overcome Regulatory, compliance, remediation and quality assurance challenges
  • Road map for the products already registered with one HA to register with other HA to enhance business
  • Post-approval changes submission strategy for the proposed changes to maintain the compliance and to submit supplement/variation/amendment to minimize the manufacturing/Regulatory cost to the client and for quicker approval
  • Country-specific intelligence to support entry into new markets for existing products
  • On-demand Expertise - Virtual Regulatory Team

Partners

Freyr enables leading pharmaceutical and life sciences organizations to drive digital transformation through its strong Regulatory Solutions and Services portfolio.

Global Data Center Partners

Technology Partners