Biopharma development & formulation intelligence
We develop AI-powered products that help biopharma teams and CDMOs make better development decisions, see risk before it becomes delay, and connect critical scientific, operational and regulatory information.
The problem
Critical scientific, analytical, quality, partner, regulatory and operational information still lives in separate teams and separate systems. Gaps surface late. Risks surface later. Programs lose time to information that already existed somewhere in the organisation.
We build the products that connect it.
BioXion
BioXion is an AI-powered biopharma development intelligence platform that connects development, analytical, quality, partner, regulatory, supply chain and operational information across the program lifecycle. It provides cross-module visibility, identifies development gaps and emerging risks, supports readiness assessment and regulatory alignment, and helps internal teams and external partners coordinate decisions.
01
Program development data lives in one system, CDMO performance in another, quality events in a third. BioXion aggregates the signals across key development functions into one program view.
02
By the time a signal reaches leadership it is usually already a problem. BioXion surfaces cross-functional risk while the window to act is still open.
03
BioXion is designed to connect relevant FDA, EMA and ICH regulatory intelligence with active programs and help teams identify potential alignment gaps earlier.
04
Rather than only reporting historical status, BioXion is designed to highlight emerging risks, cross-module dependencies and their potential impact on program readiness and timelines.
05
BioXion is deliberately positioned as a non-GxP decision-support layer. It can structure and connect program information without replacing the QMS, LIMS, ELN or other validated systems, and without becoming the regulated system of record.
FormulytiX
FormulytiX exists to close that gap — combining scientific data, interpretable modelling and regulatory knowledge so a formulation position can be argued while the decision is still inexpensive to change.
01
Early in development, formulation flexibility is generally greater and the scientific, operational and regulatory burden of change is lower. As development progresses, that flexibility narrows while the cost and evidence requirements of change increase.
02
Critical evidence often becomes available only after formulation flexibility has begun to narrow. Stability at target conditions, viscosity at the intended concentration, aggregation behaviour, degradation pathways, and drug–excipient and delivery compatibility may become clearer only after substantial experimental work.
03
It brings scientific data, evidence from comparable molecules, interpretable scientific modelling and regulatory context together earlier—while formulation decisions remain more flexible.
04
FormulytiX is designed to provide traceable, interpretable outputs that show the supporting evidence, assumptions, confidence and relevant regulatory context. Experimental confirmation remains essential; the platform helps teams decide where to investigate first.
Technology
NeXus is a shared AI and intelligence layer in development for the Helvetia Tech Solutions product ecosystem. It is intended to support advanced reasoning, contextual analysis and explainable, evidence-linked recommendations across BioXion and FormulytiX.
Scientific, operational and regulatory context connected in one chain of inference rather than isolated model outputs.
The same data means different things at different stages of development. NeXus keeps that context attached.
Outputs are designed to remain traceable to their supporting evidence, assumptions and development context.
Approach
We do not start with generic software features. We start with the scientific, operational and regulatory decisions biopharma teams need to make, the information they rely on, and the gaps that slow development.
Our products are shaped around real industry workflows and developed in collaboration with research, technology and industry partners.
Beyond our proprietary biopharma platforms, Helvetia Tech Solutions supports the product and technology development of IVF Companion, a digital healthcare platform led by Aleksandra Svonja.
Critical scientific, analytical, quality, partner, regulatory and operational information is still fragmented across teams and systems. I founded Helvetia Tech Solutions to build products that connect biopharma development intelligence through BioXion and advance formulation and excipient decisions through FormulytiX.
Partnerships
We are open to discussions with organisations interested in product pilots, design partnerships, scientific validation, technology collaboration or strategic investment.