What Epista Life Science does

Epista Life Science is a privately held life sciences consultancy headquartered in Hørsholm, Denmark, founded in 2009. The firm employs 200+ specialists and serves 170+ global clients across pharmaceutical, biotechnology, and medical technology organizations in Europe and North America. Its service portfolio is organized around four business areas — Clinical, Regulatory, Quality, and Commercial & Medical — supported by eight capabilities including Compliance & Validation, Migration, Data Strategy & Analytics, AI & Automation Enablement, Serialization, Training, and Audit.

The consultancy is technology-agnostic, with deep specialization in regulated-environment enterprise platforms: Veeva Vault (Quality, Clinical, Regulatory, Commercial clouds), Salesforce, and Microsoft Dynamics 365. Delivery spans advisory and assessment through implementation and ongoing managed operations, including serialization managed services and clinical data remediation engagements (e.g., a 800-study, 4-million-document program). Epista also applies generative AI for document classification, metadata extraction, validation document generation, and anomaly detection in migration pipelines, and has co-developed an AI quality impact assessment agent with partner Cegeka.

Epista generates revenue through professional services delivered via direct consulting engagements to enterprise clients. Pricing is quote-based and tailored to scope, with no public pricing disclosed. Customer concentration sits among named pharma majors including Novo Nordisk, Gilead, Genmab, Lundbeck, Ferring Pharmaceuticals, Sobi, and Fujifilm, with reported 97% of customers indicating commitment to long-term partnership. Growth has been primarily organic, supplemented by the October 2025 acquisition of Danish peer Genau & More and ongoing expansion of US operations under a dedicated General Manager.

Name

Epista Life Science

Legal name

Epista Life Science

Website

https://epista.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

101–250 employees

Short description

Epista Life Science is a Denmark-headquartered, privately held life sciences consultancy employing 200+ specialists to deliver compliance, validation, clinical, regulatory, quality, and technology services to 170+ pharmaceutical and biotech clients across Europe and North America.

Ownership category

akta.pro rank

Product category

Life Sciences Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Engineering, Accounting, Research, Management (8700), Services-Management Consulting Services (8742)

akta.pro primary industry

Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG)

akta.pro secondary industries

Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL), Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Life science consulting
• Regulatory compliance services
• Pharmaceutical validation
• Clinical operations consulting
• GxP quality consulting

Headquarters

HQ city

Hørsholm

HQ country

Denmark

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Consulting Services: Professional consulting services delivered by specialized consultants across compliance, validation, clinical, regulatory, quality, and technology domains. Services are delivered through direct client engagements with teams working hands-on at client sites or remotely.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Epista Life Science is a people-first consultancy that delivers compliance, validation, clinical, regulatory, quality, and technology consulting services to life sciences organizations. The firm works at the intersection of business, IT, and compliance, supporting pharmaceutical, biotechnology, and med-tech clients from strategy and assessment through implementation and managed operations across Europe and North America. Services are technology-agnostic and span Veeva, Salesforce, and Microsoft Dynamics 365 platforms, with growing capabilities in AI and automation enablement for GxP environments.

Product overview

Epista Life Science is a people-first consultancy operating across Europe and North America, offering a portfolio of consulting services organized around four primary business areas (Clinical, Regulatory, Quality, Commercial & Medical) and eight highlighted capabilities (Compliance & Validation, Migration, Data Strategy & Analytics, AI & Automation Enablement, Project Management, Serialization, Training, Audit). The company specializes in implementing and optimizing enterprise technology platforms including Veeva Vault and Salesforce for life sciences organizations. Service delivery spans from advisory and assessment through implementation and ongoing managed operations, with notable expertise in serialization, clinical data remediation, and AI-enabled document management. The October 2025 merger with Genau & More expanded their engineering and digitalization capabilities.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Services Consulting and advisory services for clinical trial execution, trial management system support, and clinical operations excellence, delivered to pharmaceutical and biotechnology organizations.
• Regulatory Services Regulatory submissions, information management, and document management consulting supporting life science companies through complex regulatory processes and submissions.
• Quality Services Quality management system consulting, FDA inspection preparation, cleaning validation, and quality systems optimization for life sciences organizations.
• Commercial & Medical Services CRM selection guidance, commercial engagement model transformation, and medical affairs support for life science commercial operations.
• Compliance & Validation Pragmatic, risk-based compliance consulting and validation services including ASTM E2500 implementation, computer system validation, and regulatory compliance support for life sciences.
• Migration Services Data migration consulting for regulated environments including cloud transformations, Veeva Vault migrations, and continuous migration pipeline development with AI-assisted automation.
• Data Strategy & Analytics Data architecture consulting, data mesh implementation, BI and analytics layer support, and AI/ML integration for pharma and biotech data stacks.
• AI & Automation Enablement AI readiness assessments, EU AI Act compliance guidance, GenAI implementation for document management, and AI-powered process automation for regulated environments.
• Serialization Managed Operations Ongoing serialization operations including system implementation, new market onboarding, interim SME support, and operational continuity for pharmaceutical serialization requirements.
• Training Services Industry training programs covering GMP compliance, FDA inspections, Annex 11/22 requirements, AI in pharma, and qualification/validation methodologies.
• Audit Services GMP audit support, regulatory inspection preparation, AI audit applications, and contract manufacturer oversight consulting.
• Veeva Services Specialized Veeva Vault consulting including quality management, clinical operations, regulatory affairs, and commercial cloud implementations; covers Vault optimization, release management, configuration, and system alignment.
• Salesforce Services Salesforce CRM consulting for life sciences including CRM selection support, commercial engagement model design, and Veeva-Salesforce migration planning.
• Clinical Data Remediation Program

Quantifiable outcome

• 97% of customers say Epista is committed to long-term partnerships
• +2 more outcomes

Named customers17 records

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability7 records

Feature5 records

Partnerships

Four partnerships are on record, tiered core and major.

• CegekacoreStrategic or Co-development Partner · 17 March 2026Epista and Cegeka co-host webinars on AI in Pharma, covering compliance, regulations, and GxP boundaries. The partnership combines Cegeka's AI solutions (Quality Impact Recall Agent) with Epista's regulatory and compliance expertise for life sciences.
• MicrosoftcoreTechnology or Integration · 7 February 2023Microsoft and Epista partnered on a webinar about Dynamics 365 for Life Science & Pharma, discussing how the platform provides a fully compliant, flexible, and scalable solution for pharmaceutical companies. Epista provides consulting expertise in validation and compliance for Microsoft Dynamics 365 implementations in regulated environments.
• CegekacoreImplementation/ SI/ Consulting Partner · 7 February 2023Cegeka partnered with Epista and Microsoft on Dynamics 365 for Life Science webinars. Cegeka provides validated solutions that expand Dynamics 365 capabilities for pharma companies, while Epista contributes regulatory and validation expertise. They co-present on ERP validation and compliance topics.
• Genau & MoremajorStrategic or Co-development PartnerGenau & More, a Danish engineering and consulting company specializing in life sciences, was acquired and merged with Epista Life Science. The merger aims to enhance quality, compliance, digitalization capabilities, and market reach for both companies, serving the life sciences industry.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• NNIT (now part of Novo Nordisk): Danish-headquartered IT services provider with deep life sciences focus, originally a Novo Nordisk subsidiary. Comparable GxP, validation, and Veeva/Salesforce capabilities for regulated pharma clients, often competing head-to-head in Nordic pharma RFPs.
• ZS Associates: Specialized consulting firm with strong pharma commercial and R&D practices, deep Veeva and Salesforce expertise, and significant European presence. Closely comparable client profile and platform-centric delivery model.
• Key2Compliance: Nordic-based life sciences consultancy specializing in GxP compliance, qualification, and validation. Direct competitor in Epista's home market with overlapping service offerings and similar boutique positioning.

Broad incumbents

• Accenture Life Sciences: Global consulting and SI leader with a dedicated life sciences practice covering regulatory, clinical, and quality transformations. Competes on larger enterprise deals and offers broader portfolio than Epista but with less Nordic boutique specialization.
• Deloitte Life Sciences Consulting: Big-4 consultancy with regulatory, quality, and technology transformation practices serving global pharma. Provides overlapping GxP and validation services at larger scale but with higher cost structure and broader scope.
• Cognizant Life Sciences: Global IT services firm with substantial life sciences business spanning clinical, regulatory, and commercial operations. Competes on Veeva/Salesforce implementations and digital transformation programs for pharma clients.
• IQVIA Consulting: Global clinical and commercial life sciences consultancy offering regulatory, clinical operations, and technology services. Broader scale and data assets than Epista, but overlapping in clinical and regulatory transformation engagements.
• Infosys Life Sciences: Major global SI with a life sciences vertical providing validation, regulatory, and digital transformation services. Competes on cost-arbitraged delivery and large multi-year programs for global pharma.
• TCS Life Sciences: Global IT services giant with a life sciences practice covering clinical, regulatory, and quality management transformations. Direct overlap on Veeva and Salesforce implementation work with large pharma customers.

Emerging players

• Cegeka: European IT services group with a growing life sciences practice and validated Dynamics 365 / AI solutions for pharma. Existing partner of Epista on AI-in-pharma webinars, with potential to compete or co-deliver on validation and compliance engagements.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/epistals

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Epista Life Science