Medicinal Products

Experience regulatory excellence with Freyr, where a decade of pioneering expertise ensures unparalleled standards. Our premium services, powered by elite experts and bespoke software, guarantee seamless global compliance. With customer focus at our core, we collaborate to meet your unique needs, redefining expectations together. Welcome to Freyr, where leadership, quality, and client satisfaction converge.

  • 120

    +

    Countries
  • 580

    +

    Clients globally
  • 1035

    +

    Regulatory experts
  • 6000

    +

    Submissions
  • 400

    +

    Annual report
  • 100

    +

    Regulatory assessment/ Dossier remediations
  • 50

    +

    Initial submissions
  • 550

    +

    Minor, moderate & major variations
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Transform Regulatory Compliance into Competitive Advantage

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A Strong Regulatory System Plays A Predominant Role in Shaping Innovation Trajectories

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Generics

Explore the Right Opportunities in the Right Market

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Navigate Health Authority Interactions & Pre-Submission Meetings with Expert Guidance!

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Streamline Regulatory Compliance & Accelerate Approvals!

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Medicinal Products

Pharmaceutical Regulatory Affairs Services

What it is Like to Have Freyr as Your Regulatory Partner

At Freyr, a decade is not just a measure of time, but it is also a legacy of pioneering the Regulatory service and outsourcing realm. Our tapestry of thought leadership is woven with exceptional expertise, visionary foresight, and an unwavering commitment to elevating the standards of the pharmaceutical Regulatory landscape.

Excellence: We understand that in the world of pharmaceuticals, excellence is not an option; rather, it is a necessity! We thus bring a suite of premium, high-caliber services to your doorstep. Our arsenal of Regulatory acumen is powered by a circle of in-house experts and bespoke software, crafted to help you navigate the intricate mazes of global compliance.

Customer Focus: Your business is unique, and our global team of regional experts is attuned to the nuances of your needs. We will not merely guide you – we collaborate, streamline, and innovate to ensure that your Regulatory journey is as rewarding as the destination itself.

Together, we will not only meet expectations but also redefine them. Welcome to Freyr, where leadership, quality, and customer satisfaction converge to create an unparalleled Regulatory symphony.

Pharmaceutical Expertise

Biosimilars

Over the Counter (OTC)

Over the Counter (OTC)

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Combination Product

Medical Products Regulatory Expertise

Navigating Regulations, Ensuring Innovation: Your Trusted Medicinal Products Regulatory Experts

  • Regulatory Affairs

    Global regulatory expertise for new product approvals, market authorizations, CMC, and lifecycle management, optimizing commercial potential and market success.

     

  • Pharmacovigilance

    Specializing in pharmacovigilance services, including monitoring, literature review, databases, consulting, audits, and quality assurance while prioritizing drug safety and compliance.

     

  • Publishing & Submissions

    Fast-track your medicinal product approvals globally through streamlined submissions and expert compliance guidance.

     

  • Medical Writing

    Preparing precise and meticulous clinical and nonclinical documents for regulatory submissions adhering to global guidelines.

     

  • Regulatory Labeling

    Providing tailored regulatory labeling services that ensure compliance for global market access across diverse product categories.

     

  • Regulatory Artwork

    Comprehensive regulatory artwork services, delivering compliant, integrated, and intelligence-driven solutions across the global life sciences industry.

     

  • Compliance & Audit Services

    Tailored comprehensive pharmaceutical compliance, audit, and validation services for seamless regulatory adherence.

     

  • Medical & Scientific Communication

    Enhancing Medical Communication with expert scientific writing, design, and MLR reviews, delivering innovative and cost-effective strategies for Medical Affairs and Commercialization.

     

Country-specific Medicinal Products Regulatory Consulting

Freyr Solutions provides seamless regulatory support, skillfully navigating local and international landscapes to ensure compliance across diverse frameworks. Leveraging a global presence, Freyr utilizes regional expertise and a deep understanding of local regulations, delivering precise support in key markets worldwide.

Contact Us for Medicinal Products Regulatory Expert Guidance and Support

Freyr's Approach to Medicinal Products

At Freyr, we recognize the unique challenges faced by pharmaceutical companies in the Regulatory landscape. Drawing on our deep industry knowledge and global Regulatory expertise spanning 120+ countries, we work closely with clients to identify their specific needs and requirements.

We emphasize the critical role of quality and compliance within our tailored solutions, ensuring that our clients receive comprehensive Regulatory support that meets their highest standards.

Utilizing our consultative approach, we engage in detailed discussions with clients to understand their Regulatory goals, product portfolio, and budget constraints. With a proven track record of serving 580+ clients globally, we offer insightful guidance tailored to each client's unique needs.

Through our consultative process, we address inquiries and concerns with precision, leveraging our Regulatory expertise to provide informed solutions.

Freyr offers a spectrum of specialized services tailored to meet the diverse needs of pharmaceutical companies. From Labeling and Artwork to Medical Writing, Publishing, and Submission, we leverage our extensive service portfolio to deliver customized solutions.

By establishing strategic Regulatory partnerships, we ensure long-term cost savings and maximize the value-added benefits for our clients.

At Freyr, we excel in delivering cost-effective, high-quality services with our global team of 1035+ Regulatory experts. From initial stages to final delivery, we prioritize Regulatory compliance, ensuring our clients receive unparalleled support. Beyond product approval, we provide comprehensive assistance for post-approval activities, guaranteeing ongoing compliance and Regulatory adherence.

At Freyr, client feedback is central to our commitment to continuous improvement. We actively encourage open communication to gather insights and refine our services iteratively. This client-centric approach ensures that we consistently enhance the quality and efficacy of our Regulatory support, aligning with the evolving needs of our valued clients.

Stand out in Regulatory compliance with the Freyr Advantage

Strategic Regulatory Partnership

  • More than 80% of Freyr’s Customers are engaged in Strategic Multi-Year Regulatory Partnerships for long-term guaranteed cost and benefit value gain.
  • Freyr’s growth is based on this core strategy and is heavily invested in fulfilling continuous value-driven partnerships with its customers.

One-Stop Regulatory Shop

  • Freyr provides multi-product (Pharma, Biologics, Devices, consumer), end-to-end regulatory strategy, and operational services for 120 + global markets to meet diverse customer needs.
  • Freyr’s Multi-services Regulatory approach has enabled customers to gain significant tangible benefits.

Optimized Cost Benefit

  • Freyr’s balanced multi-country delivery approach between strategy-focused local country services and mundane operational services performed from centralized low-cost country locations has benefitted Freyr customers with 25-60% cost reduction with committed quality and service level expectations.

Quality Benchmarks and Accelerators

  • Freyr has developed a number of industry benchmark artefacts for various regulatory services based on its combined historical customer project experiences.
  • These artefacts (process flows, checklists, deliverable SLAs) are quality focused and enable accelerated critical project success.

Global Regulatory Intelligence Framework

  • Freyr has invested in developing and maintaining a comprehensive Global Regulatory Intelligence Information Framework that comprises up-to-date global regulations, and HA standings in multiple regulatory topics.
  • This RI Framework is integrated into customer delivery projects for increased market specific critical success.

Regulatory Competency

  • Freyr’s Strong Global Brand Recognition as a specialized regulatory services provider that attracts high-performing talent from the industry.
  • Freyr Resources are continuously trained on the changing global regulatory landscape and are systemically driven to be competent.

ISO Certified Regulatory Practices

  • Freyr is possibly the only regulatory-focused service provider worldwide that is both ISO 9001 & ISO 27001 Certified to meet Global Health Authority Requirements in the delivery of Regulatory Projects.
  • Proven Customer confidence in data security and compliance needs.

Continuous Improvement Initiatives

  • More than 60% of customer programs delivered at Freyr are subject to year-on-year continuous improvement initiatives to provide tangible cost and efficiency benefits.
  • Freyr is committed to these initiatives in gaining continuous customer confidence and building strong long-term partnerships.