The FSP Model

Freya offers a Functional Service Provider (FSP) model for outsourcing certain regulatory functions. This model offers flexibility and allows companies to retain control of the process while leveraging Freya's expertise. Key features include:

• Dedicated Teams
  Freya's regulatory affairs experts act as an extension of your in-house team.
• Scalability
  Resources can be increased or decreased depending on the requirements of your project.
• Cost Efficiency
  Reduce costs by outsourcing only specific functions.

The RAaaS Model

Freya offers a cloud-based model, Regulatory Affairs as a Service (RAaaS), delivering on-demand regulatory services on a subscription or pay-as-you- go basis. The model leverages advanced technology and data analytics. Key features include:

• On-demand Access
  Freya's regulatory expertise and resources are available when you need them, reducing the need for in-house staff.
• Technology Integration
  The model uses Freya's digital platform and tools for efficient data management and compliance tracking.
• Cost-effective
  This model allows you to pay only for the services you use, making it economical for smaller businesses and those with fluctuating regulatory needs.

Comprehensive Outsourcing/Full-service Model

In this model, companies outsource their entire regulatory functions to Freya, including strategy, submissions, compliance, and post-marketing surveillance (PMS). Key features include:

• End-to-end Service
  Freya covers all regulatory affairs functions from strategy to execution.
• A Single Point of Contact
  This model simplifies communication by contacting and coordinating with a single service provider.
• Expertise and Experience
  This model ensures access to Freya's extensive regulatory expertise and knowledge of different markets.

Hybrid Model

Freya's hybrid model combines elements of in-house and outsourced regulatory functions. Companies retain certain core regulatory activities and outsource other functions to Freya. Key features include:

• Flexibility
  Companies can choose which functions to keep in- house and which to outsource to Freya.
• Risk Management
  This model distributes risk by controlling critical activities.
• Cost Management
  The hybrid model optimizes costs by outsourcing non-core activities to Freya.

Project-based Outsourcing

This model involves outsourcing specific Regulatory projects to Freyr rather than ongoing functions. It is ideal for companies with irregular Regulatory needs or those requiring specialized expertise for specific projects. Key features include:

• Specialized Expertise
  This model provides access to Freyr's experts for complex or unique Regulatory projects.
• Cost Control
  Fixed costs for specific projects help manage budgets effectively.
• Flexibility
  This model provides companies with the flexibility of engaging Freyr for short-term needs.

Offshore/Nearshore Outsourcing

Under this model, companies outsource Regulatory functions to Freyr's offices in different geographical locations to benefit from cost advantages and time zone differences. Key features include:

• Cost Savings
  This model entails lower operational costs due to geographical cost differences.
• 24/7 Operations
  Time zone differences allow for continuous workflow.
• Access to Global Talent
  Companies can leverage local expertise from different regions within Freyr's global network.

Co-sourcing

Both the company and Freyr share responsibility of Regulatory functions. This collaborative approach ensures mutual investment in Regulatory success. Key features include:

• Shared Responsibility
  Both parties contribute their resources and expertise.
• Collaborative Approach
  This model encourages teamwork and knowledge- sharing.
• Customizable Solutions
  The model is tailored to meet specific needs and objectives.

Regulatory Intelligence and Strategy Services

Freyr partners with companies to gain insights into Regulatory trends, policy changes, and strategic planning. Key features include:

• Proactive Compliance
  Stay ahead of Regulatory changes and mitigate risks with Freyr's insights.
• Strategic Planning
  Develop long-term Regulatory strategies based on comprehensive intelligence.
• Expert Analysis
  Conduct in-depth analysis of Regulatory landscapes with Freyr's experts.

Staff Augmentation

Freyr provides skilled Regulatory professionals to supplement in-house teams. Useful for temporary gaps or specific expertise needs. Key features:

• Flexible Staffing
  Professionals provided on temporary, contract or project basis.
• Specialized Expertise
  Access to experienced professionals with specific skills.
• Seamless Integration
  Freyr staff work alongside in-house teams ensuring continuity.

Regional/Localized Delivery through Affiliate Network

Leverage local affiliates to deliver tailored Regulatory services ensuring compliance and market entry. Key features:

• Localized Expertise
  Access affiliates with in-depth regional Regulatory knowledge.
• Customized Solutions
  Develop strategies meeting specific regional needs.
• Enhanced Compliance
  Ensure adherence to local regulations and accelerate market entry.
• Efficient Communication
  Local affiliates facilitate understanding of Regulatory landscapes.

By leveraging Freyr's outsourcing models, you can enhance compliance, optimize costs, and focus on core business. Freyr provides the flexibility and expertise to navigate complex Regulatory landscapes.