Marketing Applications
Position Your Marketing Application for Regulatory Approval
Accelerate Marketing Application Preparation
Navigating today’s global regulatory landscape is increasingly long and complex. Sponsors can’t afford mistakes or delays when it comes to preparing and submitting marketing applications – NDA, BLA, MAA, and abridged applications – to regulatory authorities around the world.
With a proven track record, Veristat delivers end-to-end marketing application expertise and assists you through every step of the regulatory approval process. Our integrated team of submission experts provides regulatory consulting, biostatistical and programming support, CDISC-compliant data standardization, medical writing, and publishing services to help you confidently plan and execute your marketing authorizations.
In addition, Veristat can act as MAA Applicant & MA Holder in the UK, EU and Switzerland on behalf of our client’s ad interim until a legal entity is established in the EEA/CH/UK or until a commercial partner has been identified. This allows our clients faster market access in the EU and provides better positioning for negotiations with potential commercial partners.
Veristat can also support clients to establish an entity in Europe and support preparation of the required Quality Management System as needed.
WHY VERISTAT
Planned marketing applications succeed.
Start your preparation and submission timeline at the outset of your pivotal trial, or at minimum a year out from your target submission date. That's not caution for caution's sake, it's what separates sponsors who submit clean applications from sponsors scrambling at the finish line.
We've built a team around that discipline: regulatory, biostatistical, and medical writing expertise under one roof, so nothing gets lost in the handoffs between disciplines. Experience doing this at scale is what lets us tell you, with confidence, exactly when to start.
How It Works
From timeline development through post-submission support, we manage the marketing application process end-to-end:
01
Develop your timeline.
We conduct a thorough gap assessment of your data and current plans, alongside any previous agency interactions and map your submission timeline against your trial milestones, and expected data availability, starting as early as possible in your development process, preferably before you have initiated your pivotal trial(s).
02
Analyze and standardize your data.
We transform your trial data into SDTM and ADaM compliant, submission-ready datasets.
03
Write every module.
Our team writes and quality-controls the full dossier, from clinical study reports through every module of the eCTD.
04
Develop and compile all regional information and labelling
05
Publish to agencies.
We handle e-publishing and submission to regulatory authorities worldwide.
06
Support what comes after.
We stay engaged post-submission, during the review period managing agency questions, providing SME input as needed, updating documents, and submitting ongoing safety updates.
Veristat's Offerings
Wherever your application needs support, from data to documentation to the agency, we've got it covered.
Clinical & Regulatory Documentation.
Clinical Study Reports, all modules of
the eCTD, Data Standardization: SDTM and ADaM compliant datasets, including ISS/ISE ADaM dataset creation.
Agency Engagement.
Negotiations with regulatory Agencies, agency meeting attendance and support (including identification of questions and company positions for briefing documents, responses to regulatory authority questions, and update of necessary documentation).
Publishing & Submission.
Full publishing services to regulatory agencies worldwide.
Post-Approval Support.
Annual reports, safety updates, pharmacovigilance and risk management plans, renewals.
VERISTAT’S PROVEN IMPACT
Supporting development through regulatory approval
These numbers reflect programs we've supported from strategy through submission.
160+
Marketing Applications
Prepared to Date
105+
Marketing Applications
Approved Globally to Date
30+
Rare Disease Marketing Application
Approvals in the past 5 years
Veristat Expertise in Strategic Consulting
Rare disease approvals.
We've helped sponsors secure approval for ultra-rare conditions, including guiding a novel biologic through US and EU approval based on a single-arm Phase I/II study.
Multi-agency success.
Our team has helped sponsors achieve regulatory success across the FDA, MHRA, EMA and Swissmedic, tailoring strategy and documentation to what each agency actually requires.
Complex submissions, not just standard ones.
No two marketing applications are the same. We bring experience navigating the unique constraints, partnership dynamics, and challenges that come with complex submissions and working with very small companies.
Global regulatory reach.
Our global marketing application support spans NDA, BLA, NDS, MAA, and abridged applications, wherever in the world your submission needs to go next.
NEXT STEPS
What's Next in the Drug Development Process
Agency Meetings
Prepare for and navigate agency questions and meetings following your submission.
Regulatory Consulting
Get strategic guidance on what comes after approval, line extensions, new indications, or global expansion.
PROOF & RESOURCES
Real Programs, Real Outcomes
Successful Preparation Strategies for NDA/MAA Marketing Applications
Download →
Advancing to Your Next Milestone – Global Regulatory Excellence Throughout the Entire Clinical Development Lifecycle
Read More →
US & EU Approval for an Ultra-Rare Hematologic Malignancy
Learn More →
Make your data ready to make its case.
A successful marketing application requires more than compiling the evidence. Veristat brings your data, regulatory strategy, biostatistics, medical writing, and submission expertise together to build a clear path to filing—and give you the direction needed to make critical decisions before, during, and after submission.
Frequently Asked Questions
Veristat supports the full range of global marketing applications, including NDA, BLA, , NDS, MAA, and abridged applications globally, providing end-to-end expertise from regulatory consulting through submission and publishing.