Expanding Globally? How to Simplify Submissions Across 120+ Countries with Freyr

For life sciences companies, expanding into global markets isn’t just an opportunity—it’s a necessity. Patients worldwide are waiting for innovative therapies, and organizations that can bring products to market quickly stand to gain both impact and advantage.

But one critical challenge often slows this momentum: regulatory submissions. Each country has its own requirements, formats, and timelines. What works for the U.S. FDA or Health Canada may not apply to regulators in Asia, Latin America, the Middle East, or Africa.

For companies entering dozens—or even hundreds—of markets, managing submissions becomes a maze of complexity.

The good news? With the right strategy and the right partner, global submissions don’t have to be overwhelming. Freyr, with proven regulatory expertise across 120+ countries, helps life sciences organizations simplify the process and accelerate their path to global success.

The Global Submission Challenge

Submitting a dossier may sound straightforward, but for global expansion, companies face challenges at every step:

• Diverse regional requirements: While the U.S. FDA and EMA rely on eCTD, some markets still use NeeS, PDFs, or even paper-based dossiers.
• Evolving regulatory guidelines: Authorities frequently update submission rules—often with little transition time.
• Language and localization: Labels, patient leaflets, and packaging must be translated and adapted for local markets.
• Inconsistent review timelines: Some regulators offer fast-track approvals, while others face backlogs, creating unpredictable review cycles.
• Lifecycle management: Approvals aren’t the end; renewals, labeling changes, and safety updates must be tracked and submitted on time.

For organizations expanding across multiple regions simultaneously, these hurdles multiply, stretching internal resources and creating risk of delay or noncompliance.

How to Simplify Global Submissions

While challenges are inevitable, they’re far from insurmountable. Leading life sciences companies adopt key strategies to simplify submissions worldwide:

• Centralize Your Publishing Framework: Instead of reinventing dossiers for each region, build a modular, core submission package that can be easily adapted. This ensures global consistency while reducing preparation time.
• Leverage Regulatory Intelligence: Compliance starts with awareness. Real-time monitoring of global regulatory updates ensures your team never submits outdated formats or misses critical requirement changes.
• Automate for Speed and Accuracy: Automation tools streamline publishing, validate dossiers against regional standards, and reduce manual effort—cutting submission timelines by up to 50% and minimizing human error.
• Plan for Localization Early: Integrate translation and labeling review early in your process. Engaging in-country experts ensures that patient-facing materials comply with local linguistic and cultural requirements.
• Partner with a Global Specialist: Outsourcing submissions to a trusted regulatory partner provides instant access to regional expertise, scalable resources, and technology-driven efficiency—allowing internal teams to focus on strategy and innovation.

Why Freyr? Global Submissions Made Simple

At Freyr, we understand that global expansion requires more than compliance—it requires speed, consistency, and confidence.

With experience managing submissions across 120+ countries, Freyr simplifies the regulatory journey for life sciences companies of every size.

Here’s how we help streamline your submissions:

• End-to-End Publishing & Submissions: From eCTD to paper-based dossiers, Freyr manages the entire lifecycle—from preparation to submission and post-approval updates.
• Automation-Driven Efficiency: Our proprietary publishing tools ensure instant dossier validation, faster turnarounds, and error-free submissions.
• Regulatory Intelligence & Monitoring: Freyr tracks evolving regulatory updates in real time, keeping clients aligned with the latest global standards.
• Localization Expertise: Our in-country specialists handle labeling, translation, and packaging compliance, ensuring full localization accuracy.
• Flexible Engagement Models: Whether you need one-off support or complete outsourcing, Freyr offers customizable engagement models to fit your operational needs.

The Business Impact

For companies, simplifying global submissions isn’t just about compliance—it’s about business outcomes. With Freyr’s support, organizations achieve:

• Faster time-to-market – Accelerated submissions mean earlier product launches and revenue generation.
• Lower costs – Reduced rework and manual effort minimize operational overhead.
• Scalability – Handle multiple markets simultaneously without overloading internal teams.
• Regulatory confidence – Submit dossiers aligned with the latest global standards, reducing risks of rejection.
• Global reach – Seamlessly expand into new regions with expert support already in place.

The Future of Global Submissions: Digital, Intelligent, and Automated

The future of regulatory submissions is digital-first. More authorities are embracing eCTD and ICH standards, while adopting cloud-based and AI-driven systems.

At Freyr, we’re at the forefront of this digital transformation—empowering life sciences organizations to achieve compliance with agility, accuracy, and speed.

With our combination of global expertise, automation technology, and real-time regulatory intelligence, we ensure your products reach patients worldwide—faster, safer, and more efficiently.

Connect with Freyr today to simplify your next global submission.