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2 min read
As North American life sciences companies look to grow globally, emerging markets such as Asia, Latin America, the Middle East, and Africa offer tremendous potential. These regions are home to rapidly expanding patient populations and rising demand for innovative therapies. Yet, entering them isn’t simple.
One of the biggest hurdles is regulatory publishing—the process of preparing and submitting dossiers that meet each country’s specific requirements. What may seem routine in the U.S. or Canada can become a complex, time-consuming challenge outside these markets. Without the right strategy, delays and rejections can quickly derail market entry.
This is where Freyr helps its customers bridge the gap, ensuring publishing and submissions are smooth, compliant, and on time.
The Challenges of Publishing in Emerging Markets
For companies used to working with the FDA or Health Canada, publishing for emerging markets can feel like navigating uncharted territory. Common challenges include:
- Different standards everywhere: While eCTD is the norm in North America, some markets still require PDFs or even paper dossiers. Each country has its own formats, templates, and timelines.
- Constantly changing requirements: Regulatory guidelines evolve quickly, often without long transition periods. Missing a new rule can mean costly rework.
- Language and localization: Labels, leaflets, and packaging inserts must be translated into local languages, with specific disclaimers. Even small errors can delay approvals.
- Unpredictable review cycles: Many agencies face backlogs and limited resources, making timelines uncertain.
- Ongoing maintenance: Even after approval, companies must manage labeling updates, safety reports, and other commitments across multiple countries.
For North American companies entering new markets, these hurdles can lead to missed opportunities if not addressed proactively.
How North American Companies Can Overcome These Hurdles
The good news? With the right publishing approach, companies can reduce complexity, improve submission quality, and speed up approvals.
Here are proven strategies:
- Centralize and Standardize: A centralized publishing framework allows teams to build dossiers from reusable modules. Instead of recreating content for every market, core documents can be adapted and localized, saving time and ensuring consistency.
- Leverage Regulatory Intelligence: Keeping up with every market’s evolving requirement is nearly impossible without help. Regulatory intelligence solutions track changes in real time, so teams always prepare submissions aligned with the latest standards.
- Automate for Accuracy: Automation tools reduce manual errors by validating formatting, metadata, and cross-references. They also strengthen version control and create clear audit trails—critical for regulator confidence.
- Plan for Localization: Professional translation and local review safeguard labeling and patient materials. By addressing localization early, companies avoid last-minute errors that could hold back approvals.
- Consider Managed Services: For many North American companies, building in-house publishing capacity for dozens of new markets isn’t practical. Partnering with a trusted regulatory provider offers access to expertise, scalable support, and faster submissions—all without overloading internal teams.
Conclusion
Regulatory publishing in emerging markets is evolving. More countries are moving toward eCTD, harmonizing with ICH standards, and adopting digital systems. AI-driven publishing and cloud-based platforms will further transform the process.
For North American companies, the takeaway is clear: those who invest early in modern publishing approaches—and partner with experts like Freyr—will be best positioned to bring their products to new markets quickly and successfully.
Why Freyr?
At Freyr, we specialize in helping North American life sciences companies expand globally with confidence. With publishing and submissions expertise across 120+ countries, we provide:
- End-to-end publishing support: From dossier preparation to final submission.
- Regulatory intelligence platforms: Real-time updates on market changes.
- Automation-driven efficiency: Cutting publishing effort by up to 50%.
- Localization expertise: Accurate translations and region-specific compliance checks.
- Flexible engagement models: From one-off submissions to fully managed services.
Ready to expand your reach into emerging markets? Connect with Freyr today to accelerate approvals, reduce complexity, and take your life sciences innovations worldwide.
