Development and Advisory
Integrated scientific and regulatory advisory, from pre-IND through approval.
Every development decision carries weight, and the sponsors who move forward with greatest clarity aren't guessing, they're working with a team that combines strategic direction, scientific expertise, and data-driven evidence to make each decision clear and defensible
Our experts guide you through the entire drug development and regulatory submission process, whether you're building your regulatory strategy from the outset, preparing to file an IND/CTA, entering pivotal Phase 3 discussions with an agency, or getting ready to submit a marketing application.
We know novel therapeutics bring complex challenges, so we've assembled a team of scientific-minded experts who understand the complexities of therapeutic development, helping sponsors move promising therapies forward for the patients who need them.
Our teams have prepared marketing applications across NDAs, MAAs, jNDAs, NDSs, and more, guiding sponsors from initial submission through regulatory approval or authorization. Veristat-prepared applications have contributed to a meaningful share of recent FDA CDER approvals, reflecting a track record our clients can build on with confidence.
Throughout every engagement, you retain full decision authority over your development program. Our role is to bring together the data, scientific judgment, and integrated expertise that give you clearer direction for each decision, not to make those decisions for you.
How It Works: Three Ways to Engage
Every program is different, so we offer three flexible ways to work together, all built around the same integrated scientific foundation.
Advisory-Only
Strategy, evidence interpretation, and development planning, delivered independently, so you get senior scientific judgment without committing to full execution.
Advisory Leading to Execution
We help you build the strategy, then carry it into execution with everything intact: recommendations, assumptions, risks, and context move forward, so nothing is lost in the transition.Embedded Advisory Oversight
For programs already in execution, our senior scientific and data experts provide ongoing oversight and strategic direction alongside your delivery team, without disrupting who owns the day-to-day work.PROOF POINTS
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170+
marketing applications supported (NDAs, MAAs, jNDAs, NDSs, and more)
105
of those received regulatory approval or authorization
4 of 50+
FDA CDER approvals in 2024 were Veristat-prepared9
regulatory approvals in 2024 aloneNEXT STEPS
What's Next in Your Drug Development Program
Regulatory and Submissions Readiness
Move from strategy to a complete, submission-ready package.
Biometrics
Put statistical design and analysis behind the decisions that move your program forward.
Clinical Trial Delivery
Execute your program with the operational team that helped design it.
Rare and Ultra-Rare Disease
Get specialized support for small, hard-to-reach patient populations.
Give every development decision clearer direction.
Your data can do more than document where your program stands. With the right scientific and regulatory expertise behind it, it can provide the direction for what comes next. Our advisory experts work alongside your team to turn evidence into clear, defensible decisions while you retain authority over your program. Share where your program stands, and one of our advisory experts will follow up.
Frequently Asked Questions
Advisory-only engagements provide strategy, evidence interpretation, and development planning independently of execution, giving you senior scientific judgment without committing to full-service delivery. Full-service engagement carries that same strategy directly into execution, with all recommendations, assumptions, and context preserved through the transition.
No. You retain full decision authority throughout every engagement. Veristat's role is to bring together scientific judgment, data, and integrated expertise to give you clearer direction for your decisions, not to make them on your behalf.
Veristat's curated therapeutic expert network has priority depth in oncology, neuroscience, rare disease, and cell and gene therapy, integrated directly into your advisory and development team.
Yes. Veristat's regulatory affairs team supports both the US FDA pathway (Pre-IND through IND, Phase 1–3, NDA/BLA, and Approval) and the EU EMA pathway (Scientific Advice through CTA, Phase 1–3, MAA, CHMP Opinion, and EC Decision).