Regulatory Strategy Consulting Competencies - Overview
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
Regulatory Strategy Consulting Competencies - Expertise
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
