Regulatory Submissions Services
Discover Veristat's regulatory submissions services for IND, NDA, BLA, and MAA. Ensure success with proven expertise, quality, and compliance for biopharma.
Regulatory Submissions Services: Ensuring Success Across IND, NDA, BLA, and MAA
Veristat’s regulatory submissions services provide unparalleled expertise and support for biopharmaceutical companies navigating the complexities of Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), Biologics License Application (BLA) or Marketing Authorization Application (MAA) submissions.
Learn More About Regulatory Submissions
Comprehensive Overview
Expert Submission Leadership Tailored to Your Needs
Navigating the intricate process of submitting INDs, NDAs, BLAs, and MAAs requires a skilled and cohesive team. Veristat’s submission leads boast over 20 years of experience in regulatory submission leadership, driving success with a 96% approval rate across more than 300 submissions. From strategy to execution, our team ensures compliance, quality, and efficiency.
Proven Track Record
Over 96% of 300+ submissions approved, with 100% delivered on or ahead of schedule.
Global Expertise
Experience leading successful submissions in the US, EU, Canada, and emerging markets like South America and Africa, and Eastern Europe.
Innovative Tools
State-of-the-art SmartSheet tools optimize planning and reporting for expedited timelines.
Rare Disease Focus
Extensive experience with rare/orphan disease submissions, including 64 in the past five years.
Pioneering Submission Excellence
Insights on streamlining regulatory success for pre-submission meetings with health authorities.
Veristat’s Expertise
30 years of science-first drug development, across every market, every modality.
Global Submission Success
Veristat has supported over 50 submissions annually, delivering across all therapeutic areas, product types, and geographies.
Faster Timelines, Without Compromise
Our team is adept at handling fast-track, Emergency Use Authorization, PRIME, and Breakthrough Therapy Designations with precision.
Resources
Insights to help you move faster
- Regulatory Writing factsheet
- White paper: Best Practices for Developing High-Quality, On-Time Submissions
- White paper: Web of Evidence: A Practical Guide to Managing Document Dependencies in eCTD Submissions
Expert Regulatory Writing
PhDs, MDs, PharmDs, and scientists create high-quality documents that reduce reviewer comments and speed approvals.
30+ Years of Proven Impact
From strategic writing to seamless project management and publishing, Veristat specializes in transforming high-stakes scientific submissions and publications into success stories.
End-to-End Submission Support
IND
Expert guidance for investigational drug applications
NDA
Streamlined support for new drug applications
BLA
Comprehensive strategies for biologics license applications
MAA
Global expertise in marketing authorization applications
Meet Our Experts
Our Document Quality Team
Steve Sibley
Vice President, Regulatory Strategy
Over 30 years of experience leading global submissions, specializing in oncology and rare diseases.
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Mark Bowlby
Senior Director, Global Submissions
25+ years in drug development with expertise in ophthalmology, neurology, and chronic pain.
Why Choose Veristat for Your Regulatory Submissions?
Veristat combines decades of submission leadership experience with innovative tools and a global reach to ensure every client’s success. Our team’s commitment to quality, speed, and compliance has established us as a trusted partner in the biopharmaceutical industry.
Related Resources
Practical insights from our regulatory experts
Contact Us
Veristat provides expert guidance and innovative solutions to streamline your regulatory submissions, ensuring success at every stage of the process. Reach out to our experienced team to discuss your unique needs today.
- Proven 96% approval rate across 300+ submissions.
- Over 20 years of leadership experience per submission lead.
- Comprehensive global expertise across all submission types.
FAQ's
Frequently Asked Questions
1. What types of submissions does Versitat support?
We specialize in IND, NDA, BLA, and MAA submissions across all therapeutic areas and geographies.
2. How does Veristat ensure submission success?
With a proven 96% approval rate, we leverage experienced teams, innovative tools, and structured planning for efficient delivery.
3. What is Veristat’s expertise in rare diseases?
We have extensive experience with rare/orphan disease submissions, completing 65 in the past five years.