Accelerating access

The escalating cost and prolonged timelines associated with drug development have prompted global regulatory authorities to focus on ways to accelerate the availability of innovative therapies in the market. Nowhere is this more critical than in the fields of oncology and rare diseases where patients often face limited treatment options and urgent clinical need.

In response, regulatory agencies have established expedited pathways for approvals and created mechanisms to encourage innovation and cross-agency collaboration, enhancing the speed and efficiency of the review process. This has strengthened global regulatory strategy for pharmaceuticals and advanced pharmaceutical regulatory strategy approaches, leading to quicker access to new treatments for patients.

But this brings its own challenges for sponsors needing to map out the most efficient way to seek approval of new therapies across multiple countries. Building a global pharmaceutical and biologics regulatory strategy or a targeted biotech regulatory strategy requires careful planning, especially when aligning with complex regulatory frameworks and maintaining a strong strategy for regulatory compliance.

In this complex environment, strategic regulatory consulting and robust regulatory strategy for drug development are essential. Many sponsors are turning to expert regulatory strategy consulting and regulatory submission support to navigate global requirements efficiently.

Download this whitepaper to learn more about:

• The drive for regulatory convergence
• The current expedited pathways available
• The complexities that persist around global approvals
• Collaboration in action: Project Orbis
• Our recommendations for sponsors