Regulatory Consulting & Planning
Navigating the transition from lab to clinic requires an interdisciplinary team of scientific experts.
Applying experience, knowledge, and insights to develop, plan and implement regulatory strategies for successful interactions with the FDA, EMA, MHRA, Health Canada, Swissmedic and other Global Regulatory Agencies.
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A strong regulatory strategy starts before your IND or CTA, and it doesn’t stop once it’s filed.
As you look to transition your compound into clinical trials, you need the right partner to guide your planning and decision-making.
Our regulatory experts provide strategic regulatory planning, cross-functional operational support, and the practical, real-world knowledge of how to present your regulatory strategy, CMC and non-clinical plans, clinical trial design, and product development goals to the regulatory agencies.
Every sponsor moving toward an IND or CTA has the same questions running in the background:
- Am I ready?
- When should I meet with the regulatory agencies?
- What questions do I need to ask?
- What data do I need to present?
- Would my product qualify for an expedited pathway?
Those aren't small questions, and getting them wrong costs real time.
180+
INDs and CTAs prepared in the past 5 years, backed by regulatory, statistical, medical/safety, and communications experts working as one team.
We've answered them enough times to know where the actual risk hides. Our regulatory, drug development, statistical, CMC and non-clinical / medical/safety experts have prepared more than 180 INDs and CTAs in the past five years, across blood disorders, cancers, cardiovascular disease, endocrine disorders, genetic disorders, respiratory diseases, women's health, and wound healing. That's the kind of experience that turns "I think we're ready" into "we know we're ready.”
How It Works
From your first regulatory question to your last agency meeting, here's how we make it work.
Veristat's Offerings
Strategy, writing, and agency negotiations, all under one roof, built around what your program actually needs next.
- Regulatory strategy and submission plan development for global clinical trial and marketing applications
- Exploration of expedited or alternate regulatory pathways for faster approval, preparing and submitting the corresponding applications
- Assistance with initial indication selection, incorporating "Quick to POC" and commercial considerations into study designs
- Non-clinical development plans
- Contract Manufacturing Organization (CMO) selection support, full Chemistry, Manufacturing and Controls (CMC) sections writing for submissions (Module 3, Module 2.3), and gap analysis
- Clinical development plans writing and review, including trial design, sample size, protocols, IBs, eCRFs, SAPs, and IAPs.
- Regulatory agency, board, and investor presentation development.
- HTA/JCA Alignment: Integration of Health Technology Assessment (HTA) and Joint Clinical Assessment (JCA) considerations early in development to ensure clinical data packages meet both regulatory and reimbursement requirements under EUnetHTA 21 and the new EU HTA Regulation (EU 2021/2282).US IND and global CTA Gap Analysis, preparation, document Writing, and submission.
- Protocol & Investigator Brochures.
- Administrative documentation
- General investigational plan
- Initial US IND
- Investigational Medicinal Product Dossier (IMPD)
- Publishing and submission to regulatory agencies
Regulatory Agency Meeting Preparation & Support
- Strategy and questions development for agency interactions
- Meeting request letters, briefing packages, meeting attendance and debrief
- Relative priority of indications or monotherapy/combination therapy
- Facilitation of communications with FDA as regulatory representative or US Agent
- Acting as main contact with EMA, MHRA, Swissmedic and other agencies, and if needed acting as applicant for companies not based in the EU
- Meeting logistics including rehearsals, transportation, building entry, foreign visitor forms
- Attendance at Advisory Committee meetings
- Tracking of clinical, non-clinical, and CMC requirements pre-IND through marketing application
Veristat Expertise in Regulatory Affairs
There are always unknown challenges when bringing novel therapeutics to market.
That’s why we have assembled an extraordinary team of scientific minded experts who have mastered the complexities of therapeutic development enabling sponsors to succeed in extending and saving lives.
That expertise runs broad. Our teams have prepared regulatory strategies, developed clinical program designs, and supported IND, NDA, BLA and MAA for programs across all therapeutic areas.
Marketing Applications
Move from strategy to data compilation, evaluation, module writing (including regional information), regulatory review to a complete, marketing application through regulatory review to market approval.
Learn more →Chemistry, Manufacturing, and Controls (CMC)
Get expert support on CMC strategy, planning, and documentation, from early development through regulatory submission and beyond.
Learn more →Make the evidence behind your program work harder and smarter.
The right regulatory strategy starts with knowing what your data can tell you, and what it means for what comes next. Veristat brings regulatory, clinical, statistical, CMC, and scientific expertise together to turn your evidence into a clear development direction and the decisions that move your program toward its next milestone.
Frequently Asked Questions
Yes. Veristat's regulatory consulting team develops regulatory strategy and submission plans for both US and global registrations, working across the FDA, MHRA, EMA, Swissmedic, and Health Canada