##  [Market Access with end-to-end Regulatory Solutions](/index%2ephp/medicinal-products/market-access-with-end-to-end-regulatory-solutions) 

# Speed Up Market Access with Full-Spectrum Regulatory Solutions

From Strategy to Submission - Your Global Regulatory Partner for Every Phase of the Product Lifecycle

[Freyr Fact Sheet](javascript:void(0))





##### One Vendor. Full Compliance. Global Reach.

- 2100
    
    \+
    
    
    
    Global Customers
- 2500
    
    \+
    
    
    
    In-house Regulatory Experts
- 120
    
    \+
    
    
    
    Countries
- 850
    
    \+
    
    
    
    In-country Regulatory Affiliates
- 25
    
    \+
    
    
    
    Strategic Hubs











- [What is Freyr’s Unique End-to-End Product Compliance Model?](#overview)
    - [Combining Consulting, Services & Technology](#end-to-end-compliance)
    - [Success Stories](#success-stories)
    - [Key Differentiators](#key-differentiators)
    - [Freyr Partnership vs. Legacy Approaches](#freyr-partnership)
- [What are Freyr’s Other Engagement Models?](#delivery-models)
    - [Tailored Outsourcing Models](#Outsourcing-models)
    - [Additional Models for Regulatory Excellence](#regulatory-excellence)
    - [Success Stories](#fr-success-stories)
- [Why is Freyr recognized as an Industry Leader?](#about-freyr)
    - [About Freyr](#fr-about-freyr)
    - [2100+ Satisfied Global Clients](#global-clients)
    - [Awards & Recognitions](#awards-and-recognitions)
    - [CSR](#awards-and-recognitions)
    - [Quality Certifications](#awards-and-recognitions)







## End-to-End Global Product License Maintenance

#### Turning your breakthroughs into real world impact - Our shared mission

We navigate the regulatory maze for you with true end-to-end product compliance ownership that scales with your mission, empowering you to focus on life-changing innovation.

Our unique model consolidates consulting expertise, operational execution, and proprietary AI technology into a fully integrated KPI-driven partnership, eliminating the need for client-side regulatory investments in people, processes, and technology. Freyr doesn’t just support regulatory compliance - we own it.











![Comprehensive Regulatory Expertise]()

###### Consulting



- Regulatory strategy during product development
- Product classification
- Optimal regulatory pathways for product registrations
- Gap analysis
- Systems consultation
- Centralization & harmonization of SOPs
- Process optimizations that eliminate redundancies & accelerate timelines
- Custom regulatory intelligence reports



![Comprehensive Regulatory Expertise]()

###### Services



- Health Authority (HA) interactions
- Meeting packages for HA
- Preparation of initial regulatory dossiers
- HA query resolution support
- Change controls assessments
- Preparation & submission of post-approval change applications
- End-to-end product life-cycle regulatory management



![Comprehensive Regulatory Expertise]()

###### Technology



![freya fusion]()  
AI-First, Cloud-Native Regulatory Platform

- Centralized ecosystem for managing registrations, submissions, labeling, artwork, documents, and regulatory intelligence
- Embedded business intelligence and Freya chatbot enable intuitive, conversational access to data and documents
- AI-powered insights for accelerated decision-making
- Integrated project planning & tracking, automated notifications, KPI monitoring, and workflow management
- Seamless automation and advanced content management
- Built on a GxP-compliant, enterprise-grade architecture ensuring security, scalability, and reliability











## Success Stories



##### Freyr Provided End-to-end Regulatory Support for Innovative Medicines Company

###### Business Imperatives

The client needed support for initial submissions such as INDs, IMPDs, NDAs, and MAAs, develop effective Regulatory submission strategies, facilitate market expansion submissions for new regions, manage post-approval lifecycle submissions and change control evaluations and support the organization of samples and certificates to meet Regulatory requirements.

###### Outcomes

Freyr successfully supported an Innovative Medicines Company in achieving Regulatory compliance and market expansion goals by managing all aspects of submissions, approvals, and lifecycle management with precision and expertise. This included ensuring timely submissions, addressing compliance gaps, and streamlining Regulatory processes to facilitate seamless entry into new markets.

[Know More](https://www.freyrsolutions.com/success-stories/freyr-provided-end-to-end-regulatory-support-for-innovative-medicines-company)





##### Freyr Provides End-to-End LCM Support for Managing Pharma Portfolio Across Global Markets for a Biopharma Company

###### Business Imperatives

The client needed support in assessing product changes, extending dossiers to new markets, managing renewals and reports, remediating legacy dossiers, and streamlining submissions to ensure compliance and Regulatory efficiency.

###### Outcomes

Freyr successfully managed the pharmaceutical product portfolio across the USA, LATAM, Europe, Middle East, Africa, APAC, and CIS countries, ensuring compliance with regional Regulatory requirements.

[Know More](https://www.freyrsolutions.com/success-stories/freyr-provides-end-to-end-lcm-support-for-managing-pharma-portfolio-across-global-markets-for-a-biopharma-company)













## Key Differentiators: Why Freyr’s Model is Unmatched

###### Gain access to a globally unified regulatory model that no other provider can match - combining deep domain expertise, global reach, and Local Health Authority insights. It's a partnership built for precision, scalability, and procurement value.

- [Performance-Guaranteed, KPI-Driven Ownership](#medicinal-products)
- [Technology Included - Not an Upsell](#medical-devices)
- [Multi-Year TCO Clarity](#cosmetics)



- [Exclusive Strategic Benefits](#home)

- 100% On-time renewals
- 72-hour Response SLA for regulatory   
    inquiries
- 5-year TCO reduction   
    (30–40% savings vs. in-house)









- [Unmatched Credentials](#home1)

- 80% AI Regulatory technology   
    automates 80% of submissions
- Real-time Global License Dashboard for   
    real-time market tracking
- Zero Zero tech deployment costs









- [Structured for Partnership](#home2)

| Cost Factor | Traditional Model | Freyr Model |
|---|---|---|
| People | Salaries + training + turnover | Included |
| Technology | $250K+ in software/licenses | Included |
| Process | Consultants + rework costs | Included |
| Risk | Fines for missed deadlines | Freyr assumes liability |























## The Freyr Partnership vs. Legacy Approaches

###### Simplify your vendor landscape, amplify your impact. Drive your business outcomes with a singular strategic partnership delivering what multiple vendors, platforms and systems can’t.

|  | DIY Compliance | Outsourced Fragmented Services | Freyr End-to-End Ownership |
|---|---|---|---|
| Consulting | Hire internally | Separate advisory firm | Embedded experts |
| Execution | Build a team | Multiple vendors | Single accountable team |
| Technology | Costly in-house tools | Manual processes | AI platform included |
| Cost Predictability | Budget overruns | Hidden fees | Fixed per-user pricing |
| Risk | Yours alone | Shared (but diluted) | Freyr-backed KPIs |





#### Need Full-Spectrum Regulatory Support?

Connect with Our Experts for a Tailored Compliance Roadmap.

[Schedule a Free Consultation](javascript:void(0))











## Other Engagement Models

#### Wherever You Are on the Regulatory Journey - We Meet You There

## Tailored Outsourcing Models: Scaling Regulatory Partnerships

![]() Function-based

Start Small, Win Fast

Focused task execution for operational efficiency and rapid scalability.

- Specialized Function Expertise
- Advanced Technology Access
- Operational Efficiency
- Cost-Effectiveness
- Flexible Support



![]() Market-based

Local Expertise, Global Compliance

Leverage regional insights to navigate complex regulatory landscapes.

- Local Regulatory Expertise
- Optimal Workforce Management
- Faster Market Entry & Approvals
- Local Partnerships/LR Agents
- Compliance Monitoring



![]() Product-based

Ownership Beyond Tasks

End-to-end product-level support driving lifecycle consistency and strategic value.

- Consistent Quality Standards
- Lifecycle Scalability
- Risk Mitigation
- Cost Benefits
- Niche Product Submission Expertise



![]() Project-based

Agile Execution for High-Impact Goals

Outcome-driven engagement models tailored to transformation and time-sensitive initiatives.

- Business Driven
- Product Compliance
- Harmonization of Sites
- Mergers and Acquisitions
- Health Authority Driven









## Additional Models for Regulatory Excellence

![]()



#### [Time & Material (T&M) Model ](#collapseOne)



Designed for agility, the Time & Material model enables flexible, on-demand access to regulatory expertise, ideal for projects with dynamic scope and uncertain timelines. With billing based on actual resource utilization and supported by detailed tracking and reporting, this model empowers procurement teams to retain control over budgets while scaling resources as needed-without contractual rigidity.







#### [Unit-Based Pricing (UBP) Model](#collapseTwo)



The Unit-Based Pricing model delivers structured, performance-driven engagement by assigning fixed costs to standardized regulatory deliverables. This outcome-focused approach enhances predictability, facilitates volume-based cost efficiencies, and enables procurement to benchmark performance with clarity-making it particularly effective for high-volume, multi-country regulatory operations.







#### [Fixed Price Model](#collapseThree)



The Fixed Price model offers complete financial predictability for projects with well-defined scope and deliverables. With an all-inclusive, pre-negotiated cost, this model eliminates cost overruns, simplifies procurement governance, and transfers delivery accountability to Freyr-ideal for short- to mid-term initiatives where stability and precision are paramount.







#### [FTE-Based Model](#collapseFour)



The FTE-Based model provides long-term, embedded regulatory support through dedicated professionals allocated on a full-time or fractional basis. Tailored for continuity and strategic alignment, this model allows for seamless integration with client teams, predictable pricing, and the flexibility to adjust resource levels in response to shifting priorities-ideal for evolving and enterprise-scale programs.













## Success Stories



 ![Ensuring Labeling Compliance and Regulatory Efficiency Across the US and MoW Regions](/sites/default/files/styles/large/public/success-stories-thumbnails/ensuring-labeling-compliance-thumbnail.webp?itok=eSChYlMk)



#### Ensuring Labeling Compliance and Regulatory Efficiency Across the US and MoW Regions



Delivering submission-ready ANDA labeling documents with right-first-time quality and zero “Refuse to File” instances for a European multinational pharmaceutical company.



[Know More](https://preprod.freyrsolutions.com/index%2ephp/success-stories/ensuring-labeling-compliance-and-regulatory-efficiency-across-the-us-and-mow-regions)













 ![Ensuring Compliance with Health Canada’s New Guidelines Through Comprehensive Regulatory Labeling Support](/sites/default/files/styles/large/public/success-stories-thumbnails/ensuring-compliance-with-health-Thumbnail.webp?itok=Z9Wn9fD_)



#### Ensuring Compliance with Health Canada’s New Guidelines Through Comprehensive Regulatory Labeling Support



Delivering compliant, submission-ready labeling documents aligned with Health Canada’s updated requirements for a leading Canada-based generic pharmaceutical manufacturer.



[Know More](https://preprod.freyrsolutions.com/index%2ephp/success-stories/ensuring-compliance-with-health-canadas-new-guidelines-through-comprehensive-regulatory-labeling-support)













 ![Enhancing Regulatory Compliance and Query Management for Complex Molecules Through Comprehensive Labeling Support](/sites/default/files/styles/large/public/success-stories-thumbnails/enhancing-regulatory-compliance-Thumbnail.webp?itok=gQSVMMt7)



#### Enhancing Regulatory Compliance and Query Management for Complex Molecules Through Comprehensive Labeling Support



Delivering accurate, submission-ready labeling support and efficient query management for a USA-based generic pharmaceutical company handling complex molecules across Regulatory markets.



[Know More](https://preprod.freyrsolutions.com/index%2ephp/success-stories/enhancing-regulatory-compliance-and-query-management-for-complex-molecules-through-comprehensive-labeling-support)













 ![End‑to‑End Regulatory Strategy Enabled Innovator Product Entry into the EU and the USA for an Italian Multinational.](/sites/default/files/styles/large/public/success-stories-thumbnails/End%E2%80%91to%E2%80%91End-Regulatory-Strategy-Thumbnail.webp?itok=MMRJNE6e)



#### End‑to‑End Regulatory Strategy Enabled Innovator Product Entry into the EU and the USA for an Italian Multinational



An Italy-based multinational company aimed to introduce a therapy for arthritis and muscular dystrophy to the EU and US markets but lacked expertise in FDA and EMA requirements and IND oversight. Freyr provided a regulatory strategy for IND maintenance, NDA/MAA submissions, and DMF filings, enabling market access.



[Know More](https://preprod.freyrsolutions.com/index%2ephp/success-stories/end-to-end-regulatory-strategy-enabled-innovator-product-entry-into-the-eu-and-the-usa-for-an-italian-multinational)













 ![Seamless First-Cycle USFDA Approval for a Global Pharma Company](/sites/default/files/styles/large/public/success-stories-thumbnails/Seamless-First-Cycle-USFDA-Thumbnail.webp?itok=WIaCPOHB)



#### Seamless First-Cycle USFDA Approval for a Global Pharma Company



A global pharma company sought US FDA approval and needed expert Regulatory support to avoid delays. Freyr aided the process with a submission-focused approach, enabling first-cycle success and reducing compliance risk.



[Know More](https://preprod.freyrsolutions.com/index%2ephp/success-stories/seamless-first-cycle-usfda-approval-for-a-global-pharma-company)













 ![Regulatory Strategy Enabled Approval of a Complex Biological Product with a Novel Excipient for IV Infusion](/sites/default/files/styles/large/public/success-stories-thumbnails/Regulatory-Strategy-Enabled-Approval-Thumbnail.webp?itok=egucpo0T)



#### Regulatory Strategy Enabled Approval of a Complex Biological Product with a Novel Excipient for IV Infusion



A company working on a complex biological IV infusion faced the challenge of incorporating a novel excipient into its formulation. Freyr provided support by developing a strategy that managed product complexity, strengthened regulatory positioning, and facilitated progress toward approval.



[Know More](https://preprod.freyrsolutions.com/index%2ephp/success-stories/regulatory-strategy-enabled-approval-of-a-complex-biological-product-with-a-novel-excipient-for-iv-infusion)















  PreviousNext  

 

 



 









#### Procurement Decisions Define Regulatory Success

Select a partner who aligns with your vision for cost control, continuity, and compliance integrity.



[Speak to our Procurement Alignment team!](javascript:void(0))















## Why is Freyr Recognized as the Industry Leader?

##### The largest global regulatory solutions and services company in the life sciences industry

We support large, medium, and small size global life sciences companies (Pharmaceutical \| Generics \| Medical Device \| Biotechnology \| Biosimilar \| Consumer Healthcare \| Cosmetics) in their entire Regulatory value-chain, ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc., to Post-approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions. Freyr is also expanding its footprint into other key areas like Pharmacovigilance.

Headquartered in New Jersey, USA, Freyr has regional offices across the UK, Germany, South Korea, Switzerland, UAE, Canada, Colombia, Mexico, Chile, Peru, Brazil, Singapore, Australia, Malaysia, South Africa, Thailand, Hong Kong, Nigeria, New Zealand, Sri Lanka, Poland, China, Japan, and a Global Delivery Center in Hyderabad, India.





## 2100+ Satisfied Global Clients

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- [Awards & Recognitions](#mdv-1)
- [Corporate Social Responsibility](#mdv-2)
- [Freyr’s Quality Certifications](#mdv-3)

![Freyr Regulatory-Affairs]()

[Freyr Recognized as a Leader by Everest Group in Life Sciences Regulatory and Medical Affairs Operations, PEAK Matrix® Assessment 2024](/press-releases/freyr-recognized-as-a-leader-by-everest-group-in-life-sciences-regulatory-and-medical-affairs-operations-peak-matrixr-assessment-2024)





![]()

[Freyr Solutions Recognized as a "Great Place to Work in 2024" by Forbes India](/press-releases/freyr-solutions-recognized-as-a-great-place-to-work-in-2024-by-forbes-india)



![Best Industrial Regulatory Solutions Company 2024 - India]()

[Best Industrial Regulatory Solutions Company 2024 - India](/press-releases/best-industrial-regulatory-solutions-company-2024-india)



![Best Global Life Science Regulatory Services Provider 2024 – Client Service Excellence Award]()

[Freyr Solutions Receives the Prestigious “Best Global Life Science Regulatory Services Provider 2024 – Client Service Excellence Award”](/press-releases/best-global-life-science-regulatory-services-provider-2024-client-service-excellence-award)



![Innovation Award Winner 2024]()

[Freyr Secures First Place as ‘Innovation Award Winner’ at 2024 SEHTA Healthcare Business Awards](/press-releases/freyr-secures-first-place-as-innovation-award-winner-at-2024-sehta-healthcare-business-awards)







[Know More](/awards-recognitions)







- ![]()
    
    #### Freyr Solutions Embraces the Spirit of Giving During Joy of Giving Week with CSR Initiative for Aadarana Trust Children
- ![]()
    
    #### Sopot Beach Cleanup: A Step Toward Sustainability
- ![]()
    
    #### Freyr UK Gives Back: A Day of Community Building
- ![]()
    
    #### Pantry donations in the UK

[Know More](/corporate-social-responsibility)





#### ![]() [ISO 13485 : 2016](/sites/default/files/images/iso-13485-certificate.pdf)

Provision of Global Consulting Services Applicable to the Medical Device and In Vitro Diagnostic (IVD) Industry for





#### ![]() [ISO 27001 : 2013](/sites/default/files/images/ISO-27001.pdf)

Information Security Management Services cover the Software and Regulatory Services of the following departments





#### ![]() [ISO 9001 : 2015](/sites/default/files/images/ISO-9001.pdf)

Quality Management System covers the following departments







[Know More](/compliance-wall)