From strategic writing to seamless project management and publishing Veristat specializes in transforming high-stakes scientific submissions and publications into success stories.
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.
Veristat can provide or augment your own staff across the breadth of Regulatory consulting, strategy, and leadership needs.These include planning submission strategy, driving and leading consultations with health authorities, and guiding your team through the submission process.
When planning delivery of a submission, Veristat can provide expert, experienced authoring support for any and all documents across all 5 eCTD Modules
More than two-thirds of our writers have advanced degrees and come from backgrounds in CMC, Nonclinical, and Clinical.
Veristat has a team highly experienced submission leads and submission project managers who will partner with you from pre-kickoff meeting through submission. These individuals will lead our team (and can lead yours as well if needed) while partnering closely with your submission team to coordinate activities, serve as your primary point of contact with Veristat, and build and maintain a fully detailed submission timeline and content plan.
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Veristat’s expert Regulatory Operations team will compile, publish, and submit your eCTD submissions through the relevant gateway for your submission, and continue providing life cycle maintenance support throughout the life of your product.
Global reach across the US, EU, Canada, South America, Africa, and Eastern Europe
Expert Submission Leadership Tailored to Your Needs
Navigating the intricate process of submitting INDs, CTAs, 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 93% approval rate across more than 500 submissions. From strategy to execution, our team ensures compliance, quality, and efficiency.
State-of-the-art SmartSheet tools optimize planning and reporting for expedited timelines.
Global Expertise
Experience leading successful submissions in the US, EU, Canada, and emerging markets like South America and Africa, and Eastern Europe.
Rare Disease Focus
Extensive experience with rare/orphan disease submissions, including 143 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.
Expert Medical 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.
OUR OFFERINGS
End-to-end Submission Support
IND Submissions
Expert guidance for investigational drug applications.
NDA Submissions
Streamlined support for new drug applications.
BLA Submissions
Comprehensive strategies for biologics license applications.
MAA Submissions
Global expertise in marketing authorization applications.
Meet our experts
Steve Sibley
Vice President, Regulatory Strategy
Over 30 years of experience leading global submissions, specializing in oncology and rare diseases.
Mark Bowlby
Senior Director, Global Submissions
25+ years in drug development with expertise in ophthalmology, neurology, and chronic pain.
WHY US
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.
rare/orphan disease submissions in the past five years (flagging: FAQ says 65, needs reconciliation
30+ years
of science-first drug development experience
PROOF & RESOURCES
Real Programs, Real Outcomes
Authoring & Assembling IND and CTA Applications
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Best Practices for High-Quality Submissions
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What's Next in the Drug Development Process
Medical Writing
Expert documentation to support approvals.Learn More
Biometrics
Biometrics Expertise for Clinical Trials and Regulatory Submissions
Regulatory Affairs
Expert guides through the entire drug development and regulatory submission process to help you achieve regulatory success.
Frequently Asked Questions
Veristat reports a 93% approval rate across more than 500 regulatory submissions, with 100% delivered on or ahead of schedule.
Yes. Veristat's regulatory submissions team has experience leading successful submissions across the US, EU, Canada, and emerging markets including South America, Africa, and Eastern Europe.
Yes. Veristat's team has experience handling Fast Track, Emergency Use Authorization, PRIME, and Breakthrough Therapy Designation submissions
Bring every piece together for submission.
A successful submission depends on more than strong data. Veristat brings strategy, medical writing, project management, publishing, and regulatory expertise together to turn your evidence into a complete, coordinated submission, built to meet agency requirements and keep critical regulatory milestones on track.
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