ADVISORY & DESIGN
Better decisions before spend is locked
Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.
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Regulatory affairs spans the full arc of a program, from initial strategy through IND/CTA filing, pivotal-phase agency interactions, and the marketing application itself.
Get it wrong at any one of those points, and timelines slip.
Get it right, and approval stays on track.
This service is built for sponsors at any stage of that arc.
Whether you’re setting your regulatory strategy, preparing for an IND/CTA or Phase III agency meeting, or heading into a marketing application, our regulatory affairs experts are built to move you to the next milestone.
Why Veristat?
It's the experience. Regulatory success isn't theoretical for us, it's our track record. Our regulatory affairs experts guide sponsors through the entire development and submission journey, from strategy through marketing application, with the scientific depth to handle whatever complexity your program brings.
Behind that track record is a team that has genuinely mastered the complexities of therapeutic development, work that translates directly into faster, cleaner paths to approval for the sponsors we support.
HOW IT WORKS
Every regulatory journey follows a path, and we're with you at every step of it.
Set your strategy.
Prepare your filing.
Engage the agency.
Submit and publish.
Reach approval
Delivering Regulatory Insights For Accelerating Success
Regulatory Consulting
Apply our knowledge and insights to plan and implement regulatory strategies for successful interactions with Regulatory Agencies.
Learn more →Marketing Applications
We help prepare, write and defend your marketing applications with the global regulatory agencies.
Learn more →Clinical Operations
Feasibility, site selection and management, recruitment and retention, monitoring, and project management
Learn more →Biometrics
We write clinical trial and regulatory documents tailored to meet the specific requirements of the product, therapeutic indication, and regulatory agency.
Learn more →Medical Devices and IVDs
We offer proven regulatory advice and operational support for medical device and IVD development pathways to obtain the CE mark in Europe.
Learn more →Chemistry, Manufacturing, and Controls (CMC) Expertise
Tailored CMC support throughout the entire development journey to help plan manufacturing and analytical programs and generate documentation crucial for successful regulatory filings.
Learn more →PROOF POINTS
A Track Record Built on Regulatory Success
04
Veristat prepared the marketing applications for 4 out of the 50+ FDA CDER approvals in 2024.
2 out of 3
Nearly 2 out of every 3 marketing applications Veristat has prepared have received regulatory approval or authorization.
09
regulatory approvals delivered by Veristat teams in 2024 alone
170+
marketing applications supported; 105 received approval/authorization.
WHAT'S NEXT
What's Next in the Drug Development Process
Regulatory Writing Services
Coordinated writing, submission leadership, and document quality, from first draft to filing.
Clinical Operations
Recruitment, retention, and monitoring to keep your trial on track toward submission.
Adaptive Designs
Build flexibility into your trial design using simulation and biostatistics expertise.
Wherever you are in the regulatory journey, we've been there before.
From first strategy conversation to marketing application approval, our team has guided sponsors through every stage of this process, again and again. Share a few details about your program, and one of our regulatory experts will follow up to talk through what's next.
Frequently Asked Questions
Regulatory consulting focuses on strategy, planning and implementing the regulatory approach for successful agency interactions, while regulatory operations covers execution, including publishing, submission management, and the day-to-day work of getting documents to the agency correctly and on time.