Biopharma Development Intelligence · Pharma & CDMOs
See risk before it becomes a delay
BioXion is an AI-powered biopharma development intelligence platform connecting development, partner, quality, analytical, regulatory and operational information — giving teams cross-module visibility, risk detection, readiness scoring and regulatory alignment in one ecosystem.
From development planning to external partner execution and lifecycle oversight — one connected intelligence platform for biopharma and CDMOs.
v1.0 LIVE
BioXion v1.0 is now live. Program Development — launching with the Novel Programs route — together with the Program Intelligence Dashboard and AI Insight forms the first operational layer of the BioXion intelligence ecosystem.
Your program is running blind. Your tools aren’t built to fix that.
Biopharma execution is fragmented across internal functions, external partners and specialised systems. Development plans live in one place, partner commitments in another, analytical signals in a third and quality events in the QMS. The information exists — but the cross-functional picture is assembled too late.
BioXion is built to connect that fragmented operating picture. It structures information across development, external partners, analytical, quality, regulatory and supply activities, then surfaces cross-module signals for expert review before isolated issues cascade into timeline, readiness or regulatory consequences.
01
No one sees the full picture
Development, partner, analytical, quality and regulatory information is fragmented across teams and systems. Cross-functional impact is hard to see early.
02
Decisions are made without context
By the time a signal reaches leadership, it’s already a problem. The window to act has closed.
03
Regulatory gaps appear at inspection
Regulatory expectations, analytical readiness and partner execution evolve in parallel. Gaps become visible only when teams manually connect the evidence.
04
You’re managing the past
Systems of record explain individual events. Leadership still has to determine what those events mean for the wider program, partner network and next decision.
The platform
Two primary pillars. One intelligence ecosystem.
BioXion is built around two primary pillars: Program Development and Partner Programs. Quality, Analytical, Supply Chain and Regulatory Intelligence extend the wider platform ecosystem. Together, these form six intelligence modules that organisations can combine around their operating model.
✦AI Insight is the cross-cutting intelligence layer, not a standalone module or chatbot. It turns structured information from the modules in use into explainable, advisory and editable narratives, risk signals and decision context. Outputs remain traceable and subject to expert review.
Live in v1.0
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Live in v1.0 · Novel Programs
Program Development
One module for development intelligence — starting with novel programs
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Program Development supports Novel Programs in v1.0 and expands in Phase 2 with dedicated Biosimilars and Generics routes. Each route is tailored to the development and regulatory pathway relevant to that type of program, from early development through commercial and lifecycle stages.
Phase 2 · Future expansion
Program Development · Phase 2
One module. Three development routes.
Novel Programs continues from v1.0, while Biosimilars and Generics are added in Phase 2 as dedicated routes within Program Development.
Live in v1.0
Novel Programs
Original and innovative development programs across BioXion's supported therapeutic modalities, with phase-, modality- and market-specific roadmaps.
Phase 2
Biosimilars
Reference-product-led development with biosimilarity evidence, analytical and functional comparability, bridging strategy and market-specific regulatory readiness.
Phase 2
Generics
Reference-product-led generic development with API and drug-product CMC, formulation and dissolution strategy, bioequivalence planning and abbreviated regulatory pathways.
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Phase 2
Partner Programs
Track every partner commitment — before it becomes a program risk
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External development and manufacturing intelligence for pharma, biotech and CDMOs. Manage outsourced tech transfer, method transfer, manufacturing and testing workstreams; governance/QAG actions, dependencies, capacity, deliverables, decisions and partner performance. CDMOs receive a client-specific “Client’s Programs” view. Partner Programs can operate independently of Program Development.
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Phase 2
Analytical Intelligence
Catch method failures before they delay your submission
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Method lifecycle, qualification, validation and transfer intelligence with structured trending, anomaly signals and method-transfer risk visibility. Designed for internal and outsourced analytical networks, with relevant signals connected to Lifecycle Intelligence and, where applicable, Program Development readiness.
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Phase 2
Quality Intelligence
Connect quality events to the programs they affect
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Cross-site visibility across deviations, CAPAs, change controls, complaints, audit findings and readiness signals. BioXion remains a non-GxP intelligence layer that supports visibility and follow-up while source records, approvals and regulated quality workflows remain in the QMS.
On the roadmap
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On the roadmap
Regulatory Intelligence
Know your submission gaps before the agency finds them
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Regulatory Intelligence is designed to support monitoring of relevant regulatory developments and program-specific readiness and gap visibility for expert review across major markets.
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On the roadmap
Supply Chain Intelligence
Surface supply risk before it disrupts your clinical timeline
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Structured visibility into material availability, CDMO capacity, and cold-chain considerations — linked to active manufacturing campaigns and clinical milestones.
Intelligence architecture
The right view for how your organisation works
BioXion separates development-program intelligence from broader lifecycle intelligence so organisations can use the platform with or without the Program Development module.
01 · LIVE
Program Intelligence
The Program Development-linked view for phase-aware readiness, milestones, risks and regulatory context. When Program Development is included, this is the primary program dashboard.
02 · PLANNED v2.0
Lifecycle Intelligence
A broader cross-module view designed to surface lifecycle context, emerging risks and cross-functional impacts across the BioXion capabilities an organisation uses.
Connected partner ecosystem · planned v2.0
Work with the right partner — and keep the relationship visible
Partner Programs extends beyond oversight. BioXion is designed to support both partner discovery and structured collaboration while keeping observed customer-specific performance private to each tenant.
CONNECT
BioXion Connect
A secure collaboration layer for sponsors and external partners working across shared development programs. BioXion supports controlled information exchange while authoritative regulated records remain in existing source systems.
PIN
Partner Intelligence Network
AI-assisted partner discovery and qualification support using structured partner intelligence. BioXion helps teams identify relevant CRO/CDMO capabilities and assess potential partner fit while customer-specific observed performance remains tenant-private.
Platform preview
Program readiness today. Lifecycle visibility next.
The live Program Intelligence Dashboard provides a program-focused view of readiness, milestones and risk. Lifecycle Intelligence is planned to extend cross-module visibility across partner, quality, analytical and later operational capabilities.
Program Intelligence Dashboard
Readiness · Open risks · Active milestones · Regulatory signals
✦ AI-powered
Built for decision makers
For the leaders who can’t afford to be the last to know
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Portfolio visibility
Programs, external workstreams, partners and sites brought into a connected view — reducing the manual effort required to assemble leadership context.
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Readiness scoring
Structured readiness signals based on the modules and program context in use — with the underlying factors visible for expert review.
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Strategic signals
Cross-module signals surfaced with context so teams can assess emerging risks, dependencies and readiness gaps earlier.
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BioXion doesn’t replace your systems — it gives you a unified view across them.
BioXion can start with structured entry and supported imports, then evolve toward selected APIs and connectors. Existing QMS, LIMS, ELN and project systems remain the authoritative source for their regulated or specialised records.
Use cases
Where BioXion delivers impact
Program Development Planning
BioXion provides development roadmaps tailored to program modality, stage and market context from preclinical through commercial and post-approval lifecycle. Program Intelligence connects the plan to milestones, risks and management context.
Partner Programs
Partner Programs is designed for outsourced development and operations — including tech transfer, method transfer, manufacturing and testing. It structures workstreams, governance, dependencies, capacity, deliverables, decisions and partner signals for sponsors, enterprise pharma teams and CDMOs. It can be used with or without Program Development and is planned for v2.0.
GMP Readiness & Risk Monitoring
Quality Intelligence is designed to connect deviation, CAPA, change-control, complaint, audit and readiness signals across internal and external sites without replacing the QMS. Source records remain authoritative; BioXion adds cross-site context, trending and follow-up visibility for expert review. Planned for v2.0.
Cross-Functional Intelligence
BioXion connects relevant information across the capabilities an organisation uses. Lifecycle Intelligence is designed to help teams identify cross-functional impacts and emerging lifecycle risks earlier, with context for expert review.
Knowledge base
Explore BioXion Intelligence Modules
Each BioXion module addresses a distinct development or operational domain while contributing to a connected intelligence model. The guides below explain the domain logic behind the platform.
No — intentionally. BioXion is a non-GxP development intelligence platform. It operates above validated systems such as QMS, LIMS and ELN and does not become the system of record for regulated GMP data. Where integrations are used, authoritative source records, approvals and regulated workflows remain in the appropriate originating system.
No. BioXion complements QMS, LIMS, ELN and project systems. It connects selected information across functions and partners into an intelligence view while the source systems remain authoritative for their specialised and regulated records.
BioXion v1.0 uses structured data entry and supported imports without requiring a mandatory integration project for initial deployment. A documented REST API and selected connectors to prioritised eQMS, LIMS and project-management systems are planned as the platform expands. Integration does not transfer regulated approval authority into BioXion.
Users can structure information directly in BioXion and use supported imports. As integrations are introduced, BioXion can exchange relevant information with external systems while authoritative records remain in the appropriate source system.
Early access partners are onboarded in a structured process designed to deliver first program visibility quickly. Onboarding timelines are an early-access design target rather than a guaranteed service level. We work directly with your team to configure the platform around your program structure and existing data.
Data is hosted in Switzerland with Swiss data residency, deployed in Azure Switzerland North with tenant-isolated hosting. Access to external AI services is controlled where applicable, and customer-specific security and AI-processing requirements can be agreed contractually.
9 modalities: Small Molecule, mAb, ADC, mRNA, Recombinant Protein, Viral Vector Vaccine, Cell Therapy, Gene Therapy, and Oligonucleotide — plus Custom Modality. Program Development is tailored to the relevant modality context.
No. Program Development spans preclinical through commercial and post-approval lifecycle, while Partner Programs and supporting intelligence modules are designed to support outsourced development, manufacturing, testing and partner operations independently of clinical stage.
BioXion is built for development and CMC leaders, external manufacturing and alliance teams, analytical and quality functions, regulatory and program leadership, and CDMO client-program teams — especially where work is distributed across multiple partners, sites and systems.
No. Partner Programs is designed as a primary pillar in its own right and can support outsourced tech transfer, method transfer, manufacturing, testing and partner governance without requiring Program Development.
No. BioXion is not the QMS and does not transfer regulated approval authority. BioXion can support non-GxP visibility and collaboration around quality-related information while the source QMS remains authoritative for regulated status and approval.
Early access is by application. We're onboarding a selected group of partners who will help shape the product. Schedule a call using the form below, or reach out directly at [email protected] — and we'll follow up within 48 hours.
Early Access
Your next program delay is already visible — if you know where to look.
BioXion gives development and operations teams a connected intelligence layer across programs, partners and functions. We’re onboarding a selected group of early access partners to validate the platform against real operating models.
No commitment required
30-minute intro call
Direct access to the founding team
Schedule a callvia Microsoft Bookings
Pick a slot that works for you
30-minute intro call with the founding team. No commitment — bring your questions, share your context, and we'll show you how BioXion fits your program reality.
