Regulatory Strategy Consulting Competencies

Freyr is supporting global Top 5 and Fortune Pharma/Biotechnology/Consumer and Medical devices companies with end-to-end strategic Regulatory services for their strategic Regulatory needs across new emerging markets like Africa including South Africa, Sub Sahara and North Africa regions. With a right Regulatory approach as a key function of business consulting, Freyr offers cost-effective product, market and Regulatory pathway strategies to Large & Small-Medium Life Sciences companies, which includes:

  • Drug Registration Pathway
  • Market Strategy Report
  • Marketing Authorization Renewal

Gap Analysis

  • Findings, recommendations, approach for transformation
  • Systems repositories, folders, and naming conventions
  • Identify triggers, processes, and workflows across functions
  • Resources, skill sets, location, cross-functional interaction, methodologies, trainings

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

Regulatory Strategy

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

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

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

Centralization

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

Latest Resources

  • Blogs

    ANVISA Becomes a Member of PIC/s Committee

    ANVISA Becomes a Member of PIC/s Committee

    Read More
  • White Papers

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Read More
  • Webinars

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner?

    Read More

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