MVP launching Q1 2026
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An AI-powered preclinical planning platform that transforms drug-development strategy from guesswork into evidence-based decision-making.
More About PreQlinic™
The Challenge We Solve
Preclinical development is a maze of interdependent studies, regulatory requirements, and strategic trade-offs. Lean biotech teams face mounting pressure to balance speed, cost, and scientific rigour whilst satisfying regulators and investors. Traditional approaches often rely on fragmented advice, generic timelines, and inconsistent institutional knowledge.
Our Upcoming Solution
Launching in early 2026, the MVP will showcase how our platform provides structured, regulator-informed preclinical blueprints that empower scientific and regulatory teams to plan with greater speed and confidence.
Drawing from a curated knowledge base of 200+ activities across CMC, bioanalysis, pharmacology, toxicology, and regulatory domains, PreQlinic™ will provide:
Integrated Roadmaps
Unites scientific, regulatory, and operational planning into one connected framework, helping teams forecast costs, anticipate bottlenecks, optimise regulatory pathways, and coordinate delivery with confidence.
Expert Insights
AI-generated commentary from specialist personas (toxicologists, CMC experts, regulatory strategists) interpreting guidance for each molecule, therapeutic area, route of administration, and indication.
NAMs (3Rs) Integration
Validated alternatives that reduce, refine, or replace animal testing whilst aligning regulatory packages with EMA and FDA guidance, demonstrating ethical innovation and scientific robustness in every submission.
Investor Readiness
Evidence-based documentation that demonstrates scientific rigour and strategic planning, transforms complex study data into clear, defensible narratives, and aligns scientific milestones with commercial and regulatory goals that investors can trust.
Who We Serve
Biotech founders, preclinical teams, investors, and development consultants who need accessible, intelligent tools to accelerate planning, align stakeholders, and make informed, regulator-ready decisions.
Our Commitment
PreQlinic™ is founded on the belief that better planning creates better science. By making expert-level preclinical strategy more accessible and transparent, we aim to help innovative therapies reach patients faster and more efficiently.
Connect with PreQlinic™
We're keen to hear from you! Whether you have questions about our platform, partnership inquiries, or simply want to provide feedback, please reach out. We value your input and are dedicated to building a solution that truly meets your needs.
About PreQlinic™
The Problem: Early-stage biotechs waste up to 30% of their preclinical budgets chasing fragmented vendors and redoing work just to satisfy regulators. This creates delays, burns capital, and kills promising programs before they even reach the clinic.
The Solution: PreQlinic™ changes this. Our platform integrates preclinical planning, regulatory documentation, and vendor management into a single, accountable workflow. Instead of chaos, founders and investors get clear milestones, real-time visibility, and regulator-ready outputs at every step.
The Opportunity: The UK and European preclinical services market alone is worth billions, with hundreds of lean biotech startups looking for faster, cheaper, and more reliable routes to clinical proof-of-concept. With growing pressure for efficiency and transparency, our model arrives at exactly the right time.
The Ask: We are initially raising an Angel round to get us through our MVP launch and into platform development. Founders have already committed capital, and we are seeking a small number of early Angel backers to anchor the round before launching a Seed round of £300k in early 2026.
The Outcome: This raise takes us beyond proof-of-concept, into client acquisition, and a Phase 1 operational platform by mid-2026. With investor-grade milestones delivered along the way, we de-risk future raises and open the door to scale.
Q&A
This section anticipates questions across six domains: technology, reliability, founder value, investor value, market, and team.
Technology & Approach
Q1: What makes PreQlinic™ different from project management software?
Traditional tools (Asana, Monday, etc.) manage tasks, not science. PreQlinic™ encodes regulatory logic, timelines, costs, and interdependencies specific to preclinical development. It doesn’t just “track work”—it predicts, sequences, and interprets work through a regulatory lens.
Q2: Is it just a database?
The database is the backbone, but the intelligence lies in how it’s interrogated. Deterministic sequencing produces compliant workstreams, discriminative logic classifies risks, and generative AI produces expert-style commentary. Together, these three layers transform raw data into actionable strategy.
Q3: Why now?
Two converging forces: (1) biotech founders are leaner, outsourcing almost everything, and (2) AI tools are finally good enough to structure domain-specific workflows with credibility. The industry is primed for a platform that saves both time and capital.
Reliability & Trust
Q1: AI is known to “hallucinate.” How do you stop that?
We constrain the system. The deterministic database sets hard boundaries; AI never invents milestones or costs outside validated ranges. Generative output is reviewable, flagged with sources, and designed to mimic expert commentary, not fabricate data.
Q2: Where does the knowledge come from?
The database is populated with regulator-anchored activities (ICH, FDA, EMA guidance), costings from real vendor quotes, and workflows from lived preclinical experience. AI acts as the explainer and contextualizer, not the originator of science.
Q3: Who signs off?
Human oversight remains essential. AI accelerates and enforces structure, but final review always belongs to founders or scientific advisors, ensuring accountability and credibility.
Value to Founders
Q1: What problem does this solve for biotech founders?
They waste up to 30% of budgets on duplicated, mis-sequenced, or regulator-rejected work. PreQlinic™ provides a single, accountable roadmap: clear milestones, costs, and investor-ready documentation.
Q2: How does it help non-technical founders?
It gives them the equivalent of a “virtual preclinical team” in a dashboard. Instead of chasing vendors and consultants piecemeal, they can see the full pathway with context for every decision.
Q3: Is this replacing CROs or consultants?
No—it orchestrates them. CROs still run studies, consultants still advise, but PreQlinic™ ensures the sequence, costs, and outputs align with investor and regulator expectations.
Value to Investors
Q1: Why would investors care?
Because poor execution is the #1 reason biotech portfolios underperform. Investors want capital efficiency and de-risked milestones. PreQlinic™ shows exactly where money goes and when value inflections are hit.
Q2: Can it really change portfolio economics?
Yes. Saving 20–30% per program compounds across a portfolio. For a VC running 10 projects, that could free £5–10m in capital for the same stage progression.
Q3: How does this affect exit or licensing?
Regulator-ready documentation, transparent milestones, and predictable execution make assets more attractive for licensing or acquisition. That directly increases investor returns.
Market & Positioning
Q1: How big is the opportunity?
The UK/EU preclinical services market is £1.5–3.6bn. Our target is the 5-10% slice spent by lean startups and venture-backed programs—an addressable £200–400m segment.
Q2: Who else is doing this?
Nobody in this format. CROs deliver science, SaaS tools deliver project management, consultants deliver advice. PreQlinic™ unifies all three into one accountable, AI-enabled workflow.
Q3: Why will startups adopt this?
Because they’re under investor pressure to spend smarter, faster, and more transparently. If one company in a cohort uses PreQlinic™, the others risk looking sloppy by comparison.
Team & Execution
We are proud of the strength of the team and the credibility of its execution pathway. PreQlinic™ was not conceived in a vacuum: it was born from lived frustrations with biotech inefficiency, then prototyped using AI itself to prove the model could work without a large tech team. This approach demonstrates the very principle the business is built on—lean, efficient, regulator-ready innovation.
Q1: None of the core team are technologists. How did you create this?
That’s exactly the point. PreQlinic™ is a business-first solution. The concept was designed from real biotech pain points—budget waste, vendor chaos, regulatory delays. We used AI itself to assemble the MVP, structuring the database, workflow engine, and commentary layers. That proves the model before a single line of custom code was commissioned.
Q2: Where is the scientific and technical depth?
The founding team covers the bases: Alastair (CEO) leads strategy, development, and marketing; Vish (COO) manages operations, investor narrative, and financing; Shellie (CSO) provides scientific/regulatory authority. Beyond the MVP, a 15% equity pool is reserved for AI/Dev hires, ensuring technical depth scales as we raise capital.
Q3: How do we know this isn’t “AI theatre”?
Because it already works. Input an indication and other parameters, and the MVP generates a compliant roadmap with expert commentary. It’s not replacing scientists—it’s codifying their workflows, then using AI to structure and explain them. Early traction will come from demonstrating this to founders and investors side-by-side.
Q4: What does the “Q” in PreQlinic™ mean?
The “Q” stands for Quality—the foundation of everything PreQlinic™ represents.
It reflects a commitment to rigor, reliability, and readiness for regulatory scrutiny—“quality by design” built into every process. From data integrity to documentation standards, Quality defines how the platform operates and how progress is measured.
PreQlinic™ exists to make that principle practical: ensuring that every preclinical program runs with the same discipline, transparency, and confidence that regulators—and investors—expect.
Meet the Team
The PreQlinic™ team has seen preclinical inefficiency from every angle - in science, regulation, operations, and investment.
Together, they bring experience across biosciences, technology integration, operations, and stakeholder engagement - all driven by a shared goal: to make preclinical delivery as disciplined, transparent, and intelligent as the science itself.
Alastair Monteith-Hodge
Founder | CEO
Alastair leads PreQlinic’s direction and growth, helping biotech founders and their investors move from discovery to delivery with greater confidence and control.
With more than thirty years in cross-border consulting, he has worked at the intersection of strategy, communication, and trust - helping global organisations manage complexity and deliver in high-stakes environments. His clients have included Fortune 500 companies such as Huawei and General Electric, as well as healthcare leaders Johnson & Johnson, Baxter Healthcare, and GSK. Through this work, he saw how weak structure and misaligned execution can erode trust and stall progress - an insight that shaped the idea behind PreQlinic™.
In recent years, he has focused on reshaping life-science ventures - leading business turnarounds, building partnerships, and improving how teams manage documentation and delivery.
He founded PreQlinic™ to put those lessons into practice: creating a more organised, transparent way to run preclinical programmes. He believes clarity builds trust, and that consistent delivery is where innovation earns its value.
Vishal Nehra
Co-Founder | COO
Vishal manages operations, finance, and partnerships, building the systems that keep every project accountable and on track.
He brings more than twenty years’ experience delivering complex, cross-functional change for global organisations including BP, Citi, BAE Systems and IBM.
Recognised for bringing structure to complexity, his assignments have involved unifying diverse processes and cultures across regions, guiding digital transformation, and aligning global teams around shared systems and standards.
In his previous roles, Vishal managed transition to cloud and AI / automation technology deployment, always with a focus on simplifying processes, improving efficiency, and strengthening data integrity - experience that now underpins PreQlinic’s approach to governance and resilience.
He is passionate about uniting people, processes, and integrating technology to create systems that are not only compliant but genuinely connected — supported by a culture that treats precision as a habit.
Shellie Davies
Co-Founder | CSO
Shellie defines the platform’s scientific and regulatory backbone, ensuring every programme aligns with real-world study design, GxP principles, and evolving 3Rs-based methodologies.
She is an experienced toxicologist and scientific leader with more than fifteen years in both in vivo and in vitro testing and study design, medical-device biocompatibility, and laboratory quality-system management. Skilled in FDA requirements for alternative in vitro methods, she has led multidisciplinary teams delivering complex studies and regulatory submissions for global pharmaceutical clients as well as for Founder-led biotech ventures.
Shellie began her career in pharmaceutical research before moving into senior roles at Wickham Laboratories and Hoeford Research. There, she oversaw GxP programmes, validation of alternative test methods, and regulatory compliance. This experience gave her a clear view of how structure, quality, and communication determine the credibility and success of scientific work.
She is focused on bridging rigorous science with practical delivery - creating pathways that help research move from discovery to clinic with greater confidence and credibility.
The team combines strategic clarity, scientific depth, and operational precision - a blend that turns complex preclinical challenges into structured, actionable progress.
PreQlinic™ reflects that same balance: rigorous in its science, transparent in its process, and built by people who believe structure and clarity are what turn discovery into delivery.
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