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BIOSpain 2025
Meet Veristat at BIOSpain, October 7 - 9, 2025
Veristat is excited to attend BIOSpain 2025, one of Europe’s largest...
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Developing treatments for neurological, psychiatric, or CNS disorders means navigating complex trial designs, subjective endpoints, and global variability, all under tight timelines. These complexities must be translated into submissions that regulators can easily review and trust. That’s where regulatory publishing expertise becomes a critical enabler, turning intricate trial data into a clear, compliant, and compelling story.
In the past two years alone, Veristat has completed five neurology-focused initial regulatory submissions, applying specialized expertise to ensure each was clear, compliant, and ready for timely agency review. This work builds on our track record of supporting over 200 clinical trials and consulting projects in neurology in the past five years, spanning neurodegenerative diseases, pain management, and mental health therapies.
Why This Matters
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Expertise Across Rare and Ultra-Rare Disorders: Roughly 20% of our neurology projects are for rare or ultra-rare diseases, where precision in data presentation is critical.
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Experience at Scale: 70% of our global operations team has neurology or psychiatry experience, ensuring your submissions reflect both regulatory requirements and therapeutic nuance.
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Proven End-to-End Support: From regulatory strategy and statistical analysis to publishing and submission, we align every step with the unique challenges of neurology programs
Featured Solution: Regulatory Publishing for a Pediatric Gene Therapy in an Ultra-Rare CNS Disorder
A mid-sized biotech company partnered with Veristat to transition from a natural history study to a Phase I/II gene therapy trial for an ultra-rare pediatric neurological disease. Our regulatory publishing and operations experts:
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Developed the regulatory strategy and provided FDA insights to guide submission planning
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Integrated biostatistics outputs and endpoint analyses into submission-ready formats
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Coordinated trial data and documentation for consistent presentation across CTD modules
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Managed technical publishing to ensure eCTD compliance and successful validation
By aligning operational execution with strong regulatory publishing, we advanced the therapy from concept to active patient treatment—while maintaining clarity, compliance, and quality at every stage.
Read the case study: Global Pediatric Full-Service Phase I/II Clinical Trial for Rare Neurological Disease
