Medicinal Products Regulatory Services

Medicinal Products Regulatory Services are essential for pharmaceutical companies to ensure global compliance of their product portfolio and ensure patient safety. Freyr offers end-to-end Regulatory services for Medicinal Products, leveraging deep industry experience to ensure that our client’s needs are met effectively.

We have large teams working in CMC, Medical Writing, Artwork, Labeling, Publishing, Pharmacovigilance, Regulatory Intelligence, RIM Data and Document Management, Technology, and Automation. Over the last 15 years, we have worked with 1850+ clients and achieved an average cost savings of more than 30 % across these engagements, while ensuring the highest standards of quality and accelerating submission timelines..

  • 120

    +

    Countries
  • 745

    +

    Clients globally
  • 1035

    +

    Regulatory experts
  • 6000

    +

    Submissions
  • 400

    +

    Annual report
  • 100

    +

    Regulatory assessment/ Dossier remediations
  • 50

    +

    Initial submissions
  • 550

    +

    Minor, moderate & major variations

Medicinal Products Regulatory Services: Managing Complex Regulations

Freyr’s Medicinal Products Regulatory expertise covers a diverse range of product categories, including Pharmaceuticals, Generics, Biologics, and Biosimilars. Our specialized consultants expertly manage new registrations, lifecycle maintenance, and post-approval changes, to ensure compliance at every stage of the product life cycle.

From clinical trial Regulatory services that accelerate approvals, to advanced pharma Regulatory support for complex submissions in highly regulated markets, Freyr empowers your team to meet global standards, while maximizing commercial potential for all types of Medicinal Products.

Freyr’s state-of-the-art Global Regulatory Intelligence tool helps our team remain updated of changing regulations in 150+ markets, to ensure we have the most recent information and are always equipped to support your product portfolios.

 

Medicinal Products Regulatory Consulting: Strategic Partner for Success

With Freyr’s Medicinal Products Regulatory consulting, pharmaceutical companies can leverage our 15+ years of experience solving problems for diverse customers across global markets.

Whether your company wants to understand the submissions requirements of a new country to evaluate market entry, understand the applicability of clinical trial data to design the most effective bridging study, or create a core dossier template which enables you to meet local Regulatory requirements in all your target countries – Freyr has been there and can assist you with all your Regulatory strategy needs.

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 pharmaceutical Regulatory consulting and partnering with customers to add value. 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! Our arsenal of pharmaceutical Regulatory affairs services is powered by a circle of practiced experts and in-house developed software crafted to help you navigate the intricate convolution of global compliance.

Customer Focus: Your business is unique, and our global team of regional experts is attuned to the nuances of your global Regulatory affairs needs. We will not merely guide you – we collaborate, streamline, and innovate to ensure that we are always discovering new ways to drive transformation within your business. We will establish an innovation council for many of our engagements and have developed more than 20 customized automation use cases to solve specific customer challenges.

Freyr’s team supports compliance across Pharmaceuticals, Generics, Biologics, and Biosimilars, providing strategic pharma Regulatory support at every stage of the lifecycle. With our proven expertise in Regulatory compliance for Medicinal Products, clients enjoy seamless pharmaceutical success whether navigating clinical trial Regulatory services or fulfilling country-specific requirements.

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

Pharmaceutical Expertise

Medicinal 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.

     

  • Regulatory Operations

    Encompassing pharmaceutical artwork, labeling, publishing, and submissions for comprehensive compliance and efficiency.

     

  • Medical Writing

    Preparing precise and meticulous clinical and non-clinical documents for Regulatory submissions adhering to global guidelines.

     

  • 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.

     

  • Global Regulatory Intelligence

    Navigate the ever-evolving medicinal products landscape armed with AI-powered Regulatory Intelligence. Leverage 24000+ regulations, policies, guidelines and HA communications from 150+ markets, at your fingertips.

     

Country-specific Medicinal Products Regulatory Services

Freyr Solutions provides seamless pharmaceutical Regulatory Affairs services, skillfully navigating local and international landscapes to ensure drug safety and Regulatory Affairs 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 for a diverse range of medicinal products.

Americas

Africa & Middle East

Asia Pacific

Europe

Contact Us for Medicinal Products Regulatory Expert Guidance and Support

Send Us a Request

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.