Biopharma development & formulation intelligence

Intelligence that movesbiopharma forward.

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.

Swiss data residencySovereign AI, Swiss-hostedNon-GxP intelligenceEU AI Act alignedEntity masking
Program HTS-204 · mAb IgG1, Phase II
BIOXION · PROGRAM INTELLIGENCE
Readiness 78%
Program DevelopmentPhase-appropriate readiness
On track
Analytical DevelopmentMethod lifecycle · validation gaps
On track
Quality ManagementDeviation trending · CAPA
Review
Supply ChainClinical demand risk
Risk
4 of 6 modules shown2 gaps flagged · 1 open risk

The problem

Development decisions are made on fragmented evidence.

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

See risk before it becomes a delay.

An AI-powered development intelligence platform for biopharmaceutical companies and CDMOs. It connects program development, partner programs, analytical, quality, regulatory and supply chain data — and gives leadership the visibility to act before programs fall behind.

Program HTS-204 · mAb IgG1, Phase II
BIOXION · PROGRAM INTELLIGENCE
0% readiness
Program DevelopmentPhase-appropriate roadmap · AI-scored readiness
On track
Partner ProgramsTech transfer governance · multi-site risk
On track
Analytical DevelopmentMethod lifecycle · validation gaps · OOS
On track
Quality ManagementDeviation trending · CAPA governance
Review
Regulatory IntelligenceFDA · EMA · ICH gap scoring
Aligned
Supply Chain IntelligenceCold chain · depot inventory · demand risk
Risk
Connecting program modules… 0READINESS

01

No one sees the full picture

Program development data lives in one system, CDMO performance in another, quality events in a third. BioXion aggregates the signals across every development function into one program view.

Cross-functional visibilitySix connected modules

02

Decisions made without context

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.

Early signal detectionCross-module dependencies

03

Regulatory gaps appear at inspection

FDA, EMA and ICH guidance tracked manually has no link to active programs. BioXion monitors guidance continuously and scores submission gaps per program.

FDA · EMA · ICH monitoringSubmission gap scoring

04

Most tools only report the past

They tell you what happened. BioXion is built to indicate what is about to go wrong — and what it is likely to cost the program in time.

Readiness scoringPredictive risk

05

A layer above your validated systems

BioXion is deliberately non-GxP. It structures and links program information without touching your QMS, LIMS or ELN — a decision-support layer, not the system of record for regulated GMP data.

Non-GxPSwiss-hostedEntity masking
See the platform at bioxion.tech

FormulytiX

Formulation is decided early. The evidence arrives late.

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.

GREATER FLEXIBILITYLOWER CHANGE BURDEN FORMULATION INCREASINGLY LOCKED EARLIER DECISION-RELEVANT INSIGHT DISCOVERYPRECLINICALPHASE IPHASE IIPHASE III DISCPREPH IPH IIPH III
  • Freedom to change the formulation
  • Cost and evidence burden of change
  • Earlier decision-relevant insight — where FormulytiX aims to inform the decision
  • Formulation increasingly locked
  • Greater flexibility — lower change burden

Illustrative representation; change burden varies by modality, dosage form and development programme.

01

Two curves decide a program

Early on you can still change almost anything about a formulation, and changing it costs little. Both of those facts reverse as development proceeds — steadily, and in opposite directions.

Freedom fallsCost rises

02

The evidence usually arrives after they cross

Viscosity at target concentration, aggregation behaviour, degradation pathways, excipient and device compatibility — these become visible in the laboratory months into development. By then the inexpensive window has closed.

StabilityViscosityCompatibility

03

FormulytiX moves the evidence forward

It brings scientific data, precedent from comparable molecules, predictive modelling and regulatory expectations together early — so the formulation position is informed while the decision is still reversible.

PrecedentPredictive modellingRegulatory context

04

A position you can defend, not just an answer

Every output carries the reasoning that produced it — what it is based on, how confident it is, and which regulatory expectations it maps to. The laboratory still decides. FormulytiX decides where to look first.

InterpretableTraceableExperimental confirmation required
See the platform at formulytix.tech

NeXus

The intelligence layer underneath both platforms.

NeXus is the developing AI and intelligence layer designed to support advanced reasoning, contextual analysis and explainable recommendations across the Helvetia Tech Solutions product ecosystem.

  • 01
    Advanced reasoning

    Scientific, operational and regulatory context connected in one chain of inference rather than isolated model outputs.

  • 02
    Contextual analysis

    The same data means different things at different stages of development. NeXus keeps that context attached.

  • 03
    Explainable recommendations

    No output that a reviewer, partner or regulator could not follow back to its evidence.

Approach

Built around real biopharma development.

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.

Supported development — IVF Companion

Beyond our own platforms, Helvetia Tech Solutions supports the development of IVF Companion, a digital healthcare platform created by Aleksandra Svonja.

ivfcompanion.io
0Years of hands-on international industry expertise
0Proprietary biopharma intelligence platforms
0Shared AI layer powering the product ecosystem
0Digital healthcare platform supported by HTS
Sinisa Popov, Founder of Helvetia Tech Solutions
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

Let's build something meaningful.

We are open to discussions with organisations interested in product pilots, design partnerships, scientific validation, technology collaboration or strategic investment.

  • BioXion & FormulytiX opportunities
  • Industry and design partnerships
  • Research and technology collaboration
  • Strategic and investor discussions