Functional Delivery Models

The FSP Model

Freyr offers a Functional Service Provider (FSP) model, which involves outsourcing specific Regulatory functions rather than entire projects. This model provides flexibility and allows companies to maintain control over their processes while benefiting from Freyr’s expertise. Key features include:

• Dedicated Teams
  Regulatory experts from Freyr work as an extension of the in-house team.
• Scalability
  Resources can be scaled up or down, based on project requirements.
• Cost Efficiency
  Reduces costs by outsourcing only specific functions rather than entire departments.

The RAaaS Model

Freyr provides Regulatory Affairs as a Service (RAaaS), a cloud-based model where Regulatory services are delivered on demand via a subscription or pay-as-you-go basis. This model leverages advanced technology and data analytics. Key features include:

• On-demand Access
  Regulatory expertise and resources from Freyr are available when required, reducing the need for in-house staff.
• Technology Integration
  This model uses Freyr’s digital platforms and tools for efficient data management and compliance tracking.
• Cost-effective
  Under this model, you pay only for the services used, which is more economical for smaller companies or those with variable Regulatory needs.

Comprehensive Outsourcing/Full-service Model

Under this model, companies outsource the entire Regulatory function to Freyr. This includes strategy, submissions, compliance, and Post-marketing Surveillance (PMS). Key features include:

• End-to-end Service
  Freyr covers all aspects of Regulatory Affairs (RA), from strategy right up to execution.
• A Single Point of Contact
  This model simplifies communication and coordination by dealing with a single service provider.
• Expertise and Experience
  This model ensures access to Freyr’s broad range of Regulatory expertise and knowledge of different markets.

Hybrid Model

Frey’s hybrid model combines elements of both in-house and outsourced RA functions. Companies retain control over certain key Regulatory activities while outsourcing other functions to Freyr. Key features include:

• Flexibility
  Companies can choose which functions to keep in-house and which to outsource to Freyr.
• Risk Management
  This model balances risk by retaining control over the critical activities.
• Cost Management
  The hybrid model optimizes costs by outsourcing the non-core activities to Freyr.

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 the offshore/near outsourcing 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
  Under this model, companies can leverage local expertise from different regions within Freyr’s global network.

Co-sourcing

Under the co-sourcing model, both the company and Freyr share responsibility of Regulatory functions. This collaborative approach ensures that both parties are invested in the success of the Regulatory activities. Key features include:

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

Regulatory Intelligence and Strategy Services

Freyr offers Regulatory intelligence and strategy services, partnering with companies to gain insights into Regulatory trends, policy changes, and strategic planning. Key features include:

• Proactive Compliance
  This model enables you to stay ahead of Regulatory changes and mitigate risks with Freyr’s insights.
• Strategic Planning
  You can develop long-term Regulatory strategies based on the comprehensive intelligence provided by Freyr.
• Expert Analysis
  You can conduct in-depth analysis of Regulatory landscapes and implications for the business with the help of Freyr’s experts.

Staff Augmentation

Freyr’s staff augmentation model involves providing skilled Regulatory professionals to supplement the existing in-house team of an organization. This model is useful for addressing temporary resource gaps or adding specific expertise. Key features include:

• Flexible Staffing
  Freyr provides Regulatory professionals on a temporary, contract, or project basis.
• Specialized Expertise
  This model facilitates access to experienced RA professionals with specific skills.
• Seamless Integration
  Freyr’s staff work alongside in-house teams, ensuring continuity and knowledge transfer.

Regional/Localized Delivery through Affiliate Network

Freyr's regional/localized delivery through affiliate network model involves leveraging a network of local affiliates to deliver Regulatory services tailored to specific regional requirements. This model ensures compliance with local regulations and facilitates seamless market entry. Key features include:

• Localized Expertise
  This model provides you with access to Freyr’s network of local affiliates who possess in-depth knowledge of regional Regulatory requirements.
• Customized Solutions
  Through this model, Freyr helps you develop Regulatory strategies and services to meet the specific needs of different regions.
• Enhanced Compliance
  The regional model ensures your compliance with local regulations and accelerates your market entry.
• Efficient Communication
  Local affiliates facilitate better communication and understanding of regional Regulatory landscapes.

By leveraging the outsourcing delivery models offered by Freyr, you can enhance your Regulatory compliance, optimize costs, and focus on core business activities. Freyr’s tailored solutions provide you with the flexibility and expertise required for effectively navigating complex Regulatory landscapes.