Swiss pharma technology · AI-powered regulatory intelligence
Complex regulations.Intelligent solutions.Better decisions.
REGUCORE combines regulatory intelligence and artificial intelligence to help pharmaceutical professionals learn GxP, create quality documentation, assess risks and prepare for inspections with greater clarity and confidence.
Built for pharmaceutical quality, regulatory and compliance professionals.
⚙ Scène interactive des six modules · fourni par le thème, textes dans assets/js/i18n
Regulatory-grounded AI
Answers built on identified regulatory sources and approved knowledge.
Traceable information
References shown, so every statement can be checked.
Human oversight
Qualified professionals review and decide.
GxP-focused workflows
Designed around deviations, CAPA, risk, training and inspections.
Secure-by-design architecture
Security and privacy as design objectives from day one.
The REGUCORE ecosystem
One intelligent ecosystem. Multiple possibilities.
A connected suite of AI-powered tools designed for the challenges of pharmaceutical quality, regulatory affairs and GxP excellence.
Interactive prototypePlannedWhat the statuses mean
ReguCoach AIAI-powered GxP learning
AI-powered GxP learning
Learn GxP. Think Quality. Act with Confidence.
An adaptive learning experience that helps pharmaceutical professionals understand regulatory principles, practise decisions and build practical competencies.
Interactive prototypeInteractive GxP scenariosAI learning assistant
⚙ Aperçu d’interface ReguCoach AI · fourni par le thème, textes dans assets/js/i18n
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ReguWrite AIRegulatory and quality writing assistant
Regulatory and quality writing assistant
From regulatory knowledge to quality documentation.
An AI-assisted writing environment designed to help professionals prepare and review quality and regulatory documents.
Interactive prototypeSOP draftingDeviation reports
⚙ Aperçu d’interface ReguWrite AI · fourni par le thème, textes dans assets/js/i18n
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ReguAudit AIAudit and inspection readiness
Audit and inspection readiness
Don't wait for the inspection. Prepare for it.
An AI-assisted environment designed to simulate inspection questions, organise supporting evidence and help teams identify readiness gaps.
Interactive prototypeMock inspectionsInspector-question simulations
⚙ Aperçu d’interface ReguAudit AI · fourni par le thème, textes dans assets/js/i18n
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ReguRisk AIQuality risk management
Quality risk management
Turn risk analysis into actionable intelligence.
An AI-assisted workspace for structuring risk assessments, identifying potential failure modes and documenting risk-based decisions.
Interactive prototypeFMEA supportRisk matrices
⚙ Aperçu d’interface ReguRisk AI · fourni par le thème, textes dans assets/js/i18n
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ReguDocs AIIntelligent quality documentation
Intelligent quality documentation
Find the right information. Control the right documents.
A proposed environment to help organise, retrieve, compare and navigate controlled quality information.
PlannedSemantic document searchVersion comparison
⚙ Aperçu d’interface ReguDocs AI · fourni par le thème, textes dans assets/js/i18n
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ReguAcademyProfessional development and certification
Professional development and certification
Build expertise. Demonstrate competency.
A proposed learning and development environment for structured GxP education, competency pathways and professional progress.
PlannedRole-specific pathwaysCompetency assessments
⚙ Aperçu d’interface ReguAcademy · fourni par le thème, textes dans assets/js/i18n
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6connected modules
1shared intelligence layer
4languages: EN, FR, DE, IT
CHdeveloped in Switzerland for international teams
Interactive preview
See intelligence in action.
Three working previews. No account needed.
Interactive previews powered by sample content. No AI model, regulatory database or external system is connected. Names, records and values are fictional.
⚙ Démos interactives ReguCoach, ReguWrite et ReguAudit · fourni par le thème, textes dans assets/js/i18n
The problem we solve
Pharmaceutical compliance deserves better tools.
Regulatory work still runs on disconnected documents, spreadsheets and repeated searches. REGUCORE aims to connect them.
Today
Fragmented workflows
SOP-QA-014_v4_FINAL_final2.docxDeviation log 2026.xlsxRe: Re: CAPA wording?Search: “annex 11 audit trail”EU-GMP-Ch1.pdfTraining matrix (old).xlsxSame search, againInspection notes: missingChange tracker v3.xlsx
Each question starts a new search. Training records, procedures and evidence live in separate places.
With REGUCORE
Connected intelligence
RequirementWhat applies
SourceWhere it is written
ContextYour situation
EvidenceWhat proves it
RiskWhat matters most
ActionWhat to do next
ReviewWho decides
REGUCORE aims to make regulatory information easier to reach, workflows more connected and professional decisions better supported.
This describes the product vision. It is not a measured outcome.
Why REGUCORE
Built for the way GxP work actually happens.
Six principles shape every module.
Regulatory intelligence
Connect questions with relevant regulatory context and identifiable sources.
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Role-based learning
Adapt learning to job responsibilities, experience and competency needs.
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Practical simulation
Practise decisions through realistic scenarios and inspection-style questions.
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Documentation assistance
Support drafting, review and traceability across quality and regulatory workflows.
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Risk-based thinking
Structure risk assessments, evidence and mitigation decisions.
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Human-centred AI
Qualified professionals stay responsible for interpretation, review, approval and final decisions.
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Intelligence architecture
How the intelligence layer is designed.
One shared layer serves every module. Select a component to see its role.
⚙ Schéma d’architecture interactif · fourni par le thème, textes dans assets/js/i18n
Intended information flow
01Regulatory sources and approved knowledge
Identified, versioned inputs.
02Retrieval and contextual analysis
Relevant passages for the question.
03AI-generated assistance
Explanations, drafts or suggestions.
04References and uncertainty indicators
What it is based on, and how solid it is.
05Human review and approval
A qualified person decides.
This is the intended architecture. Actual performance, source coverage and controls depend on implementation. No AI model guarantees regulatory compliance.
Regulatory intelligence
Grounded in regulatory knowledge. Designed for real-world work.
Frameworks connect to the domains where professionals apply them. Select a framework or a domain.
⚙ Réseau réglementaire interactif · fourni par le thème, textes dans assets/js/i18n
Regulatory source cardIllustrative example
Source requirement21 CFR 211.192, paraphrased
Unexplained discrepancies and batch failures must be thoroughly investigated, whether or not the batch was distributed. The investigation extends to other batches that may be affected, and a written record is kept.
Interpretation
Correcting an issue on the spot does not remove the need to assess it. The key question is whether other batches or products could be affected.
Educational example
A fill-weight check fails on batch B-2417 and is corrected within minutes. The team still assesses the units filled before the correction and the batches run with the same set-up.
Suggested action
Open a deviation under your site procedure, document immediate actions, assess the impact on related batches and route the record for QA review.
Four layers, four colours. The platform is designed to keep sources, interpretations and suggestions visibly separate. Not legal or regulatory advice.
Solutions
Built for every role in the quality lifecycle.
Each team faces different challenges. The same intelligence layer supports them all.
⚙ Explorateur des solutions par métier · fourni par le thème, textes dans assets/js/i18n
Human expertise + AI
AI accelerates the work.GxP professionals make the decisions.
AI assists, professionals remain accountable
The platform suggests, drafts and explains. People decide and sign.
Regulatory references should be traceable
Every answer should show what it is based on.
Critical outputs need human review
Documents and decisions with GxP impact go through appropriate review.
⚙ Démo de validation humaine · fourni par le thème, textes dans assets/js/i18n
Security and trust
Designed for the expectations of regulated industries.
Security and privacy shape the architecture from the start.
These are design objectives. They are not certifications, attestations or verified controls. Hosting, validation status and certifications will be communicated only once they exist.
Design objective
Data minimisation
Collect and process only what a task needs.
Design objective
Role-based access control
Access tied to roles and responsibilities.
Design objective
Encryption in transit and at rest
Protection for data in motion and in storage.
Design objective
Tenant isolation
Each organisation’s data kept separate.
Design objective
Auditability
Traceable records of significant actions.
Design objective
Secure integrations
Controlled connections to other systems.
Design objective
Controlled data retention
Retention periods defined and enforced.
Design objective
Privacy-conscious AI workflows
Customer data not used to train shared models without agreement.
Design objective
Human approval for critical outputs
No critical output released without review.
Resources
GxP intelligence, in plain language.
Articles, guides and reports for quality and regulatory professionals.
Editorial previewCAPA
Quality Assurance · Article
CAPA Closure Is Not the Same as CAPA Effectiveness
Why closing an action and proving it worked are two different steps.
Preview outline
Editorial previewAI
AI in Pharma · Article
How AI Can Support GxP Training Without Replacing Professional Judgment
Where AI helps learning, and where people must stay in charge.
Preview outline
Editorial previewREF
Regulatory Updates · Article
From Regulatory Search to Traceable Intelligence
Moving from keyword search to answers that show their sources.
Preview outline
REGUCORE is in development. The modules on this site are product concepts. Some have interactive previews that run on sample content. We are opening conversations with pilot partners.
No. It is designed to support learning, research, drafting and preparation. Qualified people remain responsible for interpretation, review, approval and final decisions. It is not intended to replace a validated QMS or eQMS.
Not at this stage. No validation, certification or compliance status is claimed. Any GxP-relevant use will require appropriate technical controls, validation and evidence before deployment.
The intended approach retrieves passages from identified sources and approved knowledge, shows the references and flags uncertainty. Source coverage depends on implementation and licensing. Your site procedures always take precedence.
This website is available in English, French, German and Italian. Multilingual support in the modules is a design objective.
Use the Request a Demo page and select “Pilot partnership”. Tell us about your team, your priorities and the workflows you would like to test.
Let's talk
Shape the future of pharmaceutical compliance with us.
Book a demo of the interactive previews or join the pilot programme.
⚙ Bandeau défilant « Demander une démo » · fourni par le thème, textes dans assets/js/i18n