Specialist architecture and validated delivery for pharma and life sciences. Where audit readiness, regulatory traceability, and controlled delivery are foundational.
We architect and engineer systems where GxP isn't a compliance layer, it's foundational. Audit trails, version control, validation evidence, change control — not afterthoughts, but core architecture.
Multi-market complexity demands careful governance. We navigate regulatory fragmentation — different validation requirements by region, multiple approval workflows, localized compliance frameworks — without fragmenting the system. Single source of truth. Centralized governance. Local compliance. Every system is defensible under regulatory scrutiny.
Systems run on your Microsoft 365 infrastructure with formal change control, documented requirements, validated testing, and warranty accountability. Your IT teams inherit systems they can support and extend. No vendor lock-in. No external SaaS processing regulated data.
We are comfortable working within your existing governance and assurance framework, including privacy impact assessments, risk and impact assessments, validation requirements, and formal approval processes. We engineer systems that fit those controls from the outset, rather than treating them as something to work around later.
Every system passes formal GxP validation standards — CSV-aligned, with complete traceability from requirements through UAT and post-deployment evidence. Audit-ready from go-live.
We architect for regulatory fragmentation. Different validation frameworks, localized workflows, regional approval chains — all within a single system. Single source of truth. Local compliance.
Formal change control, documented approvals, immutable audit logs, version-controlled evidence. Every decision is traceable. Every change is gated.
Systems run on your Microsoft 365 environment. No external SaaS. No vendor lock-in. Your data boundary. Your governance framework. Your IT teams support the system.
CoreShare has achieved an EcoVadis Silver rating with a score of 61/100 — placing us in the top 25% of companies assessed globally for sustainability performance.
EcoVadis is the world's most trusted business sustainability ratings provider. Major pharmaceutical companies including AstraZeneca require their suppliers to be EcoVadis rated. Our Silver rating confirms CoreShare meets those requirements.
For procurement teams running supplier due diligence: our EcoVadis scorecard is available on request.
Carbon footprint, energy use, and environmental management.
Working conditions, health & safety, and diversity.
Anti-corruption, data protection, and responsible information management.
Supplier standards and responsible sourcing.
Managing 22,500+ annual HCP engagements across 60+ countries. Full GxP compliance: country-specific approval workflows, Fair Market Value controls, multi-currency handling, regulatory documentation, and immutable audit logs. 13,000 active users, ~2,000 daily interactions, complete traceability end-to-end.
End-to-end validated system for managing clinical trial operations across multiple regions — regulatory documentation, investigator communications, protocol compliance tracking, audit-ready reporting. Different approval chains by region, unified governance globally. CSV-validated delivery.
Master system for validation documentation, change control, deviation tracking, and CAPA workflows across the organization. Formal approval gating, immutable version control, regulatory evidence production. Every validation evidence package audit-ready on demand. Single source of truth for regulated change management.
GxP-compliant adverse event reporting integrated into operational workflows. Mandatory safety assessment fields, automatic escalation to medical review, regional reporting compliance, complete audit trails. Structured data capture at source — no spreadsheet re-entry, no compliance gaps.
End-to-end validated workflows for named patient supply and compassionate use programmes. Structured intake, medical evaluation gates, approval chains, regulatory documentation, fulfillment tracking. Every decision is logged, every workflow is structured for audit readiness, and compliance is built in by design.
Centralized intelligence management platform for regulatory tracking, competitive intelligence, market access data, and strategic planning. Structured intelligence capture, controlled distribution, audit trail for sensitive information. Board-ready insights from validated data.
Whether you have a defined validation scope or a process that's drifted into non-compliance, bring it to us. We'll give you a straight assessment of what can be solved, how we'd architect it, what validation looks like, and what realistic delivery looks like.