What Seal does

Seal (Opvia Ltd.) is a London-headquartered, privately-held software company founded in 2019 that provides an AI-native execution platform for GxP-regulated life sciences organizations. The company targets pharmaceutical, biotech, medical device, cell and gene therapy, and CDMO customers operating under frameworks including 21 CFR Part 11, EU Annex 11, GLP, GMP, GCP, GDP, ISO 13485, ISO 9001, ISO 20387, CLIA, and CAP. Its core customers include Paradromics, Agilent, Beckman Coulter, Skye Biologics, MiAlgae, Bioventix, Acclinate, and Latitude Pharmaceuticals, with the company claiming 50+ GxP-regulated accounts in total.

The platform centers on neil, Seal's proprietary AI execution agent, which converts SOPs, batch records, methods, and forms into controlled workflows with review gates, e-signatures, training assignments, audit trails, and validation evidence within a 48-hour build cycle. Seal offers 18 configurable blueprints (MES, QMS, QC LIMS, ELN, Inventory, CTMS, EDC, eTMF, RIMS, PLM, SDMS, LMS, CMMS, WMS, DMS, Equipment & Assets, Sample Management, Clinical Operations) and 33 workflows (Tech Transfer, Process Development, Pharmacovigilance, Batch Release, Deviation Management, CAPA, Change Control, etc.) all sharing a single data model. Validated modules are pre-built so customers avoid the revalidation projects that legacy stacks require for every improvement. Integrations span lab instruments, Rees Scientific and Monnit for environmental monitoring, and the platform supports industry-specific solutions for cell and gene therapy, 503B compounding, medical device, CDMO, and biotech startup segments.

Seal monetizes through per-system SaaS subscriptions: a Development (non-GxP) tier at $3,000 per system per month and a Production (GxP) tier at $5,000 per system per month, with custom enterprise pricing for multi-system deployments and early-stage startups. Pricing is per system rather than per user, with unlimited users included. Go-to-market is sales-led and consultative, anchored by CTAs to submit a single SOP for a 48-hour proof-of-concept build before full commitment. The company is led by Founder and CEO Will Moss, is registered in the United Kingdom as a private limited company, and discloses no external funding rounds in available sources.

Name

Seal

Legal name

Opvia Ltd.

Website

https://seal.run

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

101–250 employees

Short description

Seal (Opvia Ltd.) provides an AI-native GxP execution platform for pharmaceutical, biotech, medical device, and CDMO companies. Its proprietary AI agent, neil, converts SOPs into controlled workflows with validation evidence within 48 hours, spanning MES, QMS, LIMS, and ELN.

Ownership category

akta.pro rank

Product category

GxP Compliance & Manufacturing Execution Software

NAICS

Software Publishers (5132)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Recordkeeping, Archiving & Audit Trail (WORM/SEC 17a-4) (FSAFAOAK)

akta.pro secondary industry

LMS Integrations, Interoperability & Identity (LTI/SCORM/xAPI, SSO, APIs) (EDAFAAAI)

Keywords

• GxP compliance software
• Pharma manufacturing execution
• AI workflow automation
• Electronic batch records
• Quality management system

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. SaaS Subscription - Development Tier: Monthly subscription at $3,000 per system for non-GxP development use. Includes unlimited users & storage, full platform (MES, QMS, LIMS, ELN), 21 CFR Part 11 compliance, SSO & SAML, client/partner portals, full implementation & data migration, equipment integrations, onsite training, and AI features.
2. SaaS Subscription - Production (GxP) Tier: Monthly subscription at $5,000 per system for GxP production use. Includes everything in Development plus validation evidence from configuration/tests/reviews, one-click audit packets, and automated APR/PQR generation.
3. Custom Enterprise Pricing: For customers needing multiple systems per project (e.g., CDMOs) or early-stage startups, custom pricing is available upon inquiry.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Seal provides an AI-native GxP execution platform, powered by its AI agent neil, that transforms SOPs, batch records, methods, and forms into controlled workflows with review gates, e-signatures, training, audit trails, and validation evidence. The unified platform covers MES, QMS, LIMS, ELN, and additional systems on a single data model, enabling GxP-regulated life sciences companies to run a first controlled process within 48 hours and to evolve processes one governed version at a time without revalidation projects.

Product overview

Seal is an AI-native GxP execution platform that offers a unified system with 18 configurable blueprints (systems) and 33 workflows. The platform centers on neil, Seal's state-aware AI execution agent that transforms SOPs into controlled workflows with validation evidence. The core systems include MES (Manufacturing Execution System), QMS (Quality Management System), QC LIMS, Electronic Lab Notebook, Inventory Management, Clinical Operations, and Document Management. Additional systems cover CTMS, EDC, eTMF, RIMS, PLM, SDMS, LMS, CMMS, WMS, Equipment & Assets, Sample Management, and Clinical Operations. Workflows span Tech Transfer, Process Development, Pharmacovigilance, Automated Reporting, Environmental Monitoring, Batch Release, Deviation Management, CAPA, Change Control, Audit Management, and more. The platform serves multiple industries including Cell & Gene Therapy, Medical Device, Biotech Startups, CDMOs, and 503B Compounding Facilities. Pricing tiers include Development (Non-GxP) at $3,000/system/month and Production (GxP) at $5,000/system/month. The company is operated by Opvia Ltd., headquartered in London.

Differentiator

Problem solved

Functional benefit

Products and services

• Seal Platform
• neil — AI Execution Agent State-aware AI agent that converts SOPs, batch records, methods, and forms into controlled workflows, configures blueprints, identifies gaps before auditors, and generates validation evidence. Included with the Seal Platform subscription.
• Manufacturing Execution System (MES) Blueprint Batch records that guide production runs; captures batch data as it executes with AI-configured workflows that evolve with the process. Targeted at GxP-regulated manufacturing teams.
• Quality Management System (QMS) Blueprint Quality events with execution context; AI-configured workflows that evolve with the process, unified with MES, LIMS, and ELN. Targeted at quality leaders in regulated life sciences companies.
• QC LIMS Blueprint Laboratory Information Management System that checks results against live specifications. AI-configured methods evolve with the process, unified with MES, QMS, and ELN. Targeted at QC laboratories.
• Electronic Lab Notebook (ELN) Blueprint Turns experiments into structured evidence; AI-configured methods evolve with the process, unified with LIMS, MES, and QMS. Targeted at R&D scientists.
• Clinical Operations Blueprint EDC, CTMS, and eTMF share one data model; sites enter data once, documents file themselves, and queries resolve in context. Targeted at clinical operations teams.
• Clinical Trial Management (CTMS) Blueprint EDC, CTMS, and eTMF on one data model with AI-drafted site queries. Targeted at clinical operations and trial management teams.
• Electronic Data Capture (EDC) Blueprint eCRFs that catch errors at entry rather than at lock, with AI-drafted site queries. Unified with CTMS, eTMF, and Clinical. Targeted at clinical data management teams.
• Electronic Trial Master File (eTMF) Blueprint TMF documents file themselves by reference model, with AI-drafted gap analysis and inspection packages. Unified with CTMS, EDC, and QMS. Targeted at clinical regulatory and TMF operations.
• Document Management System (DMS) Blueprint SOPs and controlled documents with automated training triggers; AI-extracted from legacy documentation. Unified with QMS, MES, and Training. Targeted at document control and quality teams.
• Regulatory Information Management (RIMS) Blueprint Registration portfolio with proactive expiration alerts and AI-configured market mapping. Unified with QMS and Regulatory Submissions. Targeted at regulatory affairs teams.
• Product Lifecycle Management (PLM) Blueprint Recipe-driven development, one-click tech transfer, MSAT continuity, and CMC submissions rendered from the live spine. Targeted at sponsors and CDMOs.
• Scientific Data Management System (SDMS) Blueprint Instrument data captured with data integrity built in; AI-indexed for fast retrieval. Unified with LIMS, ELN, and QMS. Targeted at QC and analytical labs.
• Learning Management (LMS) Blueprint Competency-based learning management with AI-configured learning paths per role. Unified with Training and QMS. Targeted at training and quality teams.
• Inventory Management Blueprint Materials, lots, and usage tied to every run with AI-configured controls that evolve with the process. Unified with MES, LIMS, and QMS. Targeted at supply chain and warehouse teams.
• Equipment & Assets Blueprint Expired calibration blocks the batch; AI-configured schedules derived from equipment manuals. Unified with MES, LIMS, and QMS. Targeted at maintenance and manufacturing operations.
• Sample Management Blueprint Chain of custody from collection to consumption with AI-configured aliquoting workflows. Unified with LIMS, ELN, and Inventory. Targeted at biobanking and lab operations.
• Maintenance Management (CMMS) Blueprint Preventive maintenance executed on schedule with escalations enforced, via AI-configured maintenance plans. Unified with Equipment, MES, and QMS. Targeted at facilities and maintenance teams.
• Warehouse Management (WMS) Blueprint Physical location enforces lot status via AI-configured workflows. Unified with Inventory, MES, and QMS. Targeted at warehouse and logistics operations.
• Tech Transfer Workflow Transfer the process as data, with AI-configured workflows that evolve with the process. Unified with MES, QMS, and ELN. Targeted at process development and MSAT teams.
• Process Development Workflow Development and GMP on one record: the development process becomes the GMP process with AI-configured promotion rather than re-authoring. Targeted at process development and R&D teams.
• Pharmacovigilance Workflow Signal detection across every adverse event with AI-drafted MedWatch and EudraVigilance submissions. Targeted at drug safety and pharmacovigilance teams.
• Automated Reporting Workflow APRs, validation reports, and submissions generated from structured data, AI-drafted in minutes. Unified with MES, LIMS, and QMS. Targeted at regulatory affairs and quality leadership.
• Environmental Monitoring Workflow Trends caught while still in spec via AI-configured sampling and schedules. Unified with LIMS, QMS, and MES. Targeted at cleanroom and EM programs.
• Batch Release Workflow Execution, testing, and deviations pre-linked on one record with AI-drafted Certificates of Analysis. Unified with MES, LIMS, and QMS. Targeted at QA release and manufacturing operations.
• Deviation Management Workflow Deviations open with full context attached; AI-drafted root cause from historical patterns. Unified with QMS, MES, and LIMS. Targeted at quality and operations teams.
• CAPA Management Workflow Effectiveness verification as a gate rather than a checkbox, with AI-drafted CAPA plans from similar historical events. Targeted at quality systems teams.
• Change Control Workflow Implementation tracking that ensures changes actually happen after approval. Unified with QMS, MES, and Training. Targeted at quality and change management teams.
• Audit Management Workflow Audit readiness without periodic panic, with AI-drafted response packages. Unified with QMS, MES, and LIMS. Targeted at QA and compliance leadership.
• CoA Generator Workflow Certificates of Analysis generated directly from validated LIMS data with AI-drafted release packages. Unified with LIMS, MES, and Batch Release. Targeted at QC labs and QA release.
• Biobanking & Biorepository Industry Solution Consent travels with the sample, with provenance for every aliquot. Unified with ELN, LIMS, and QMS. Targeted at biobanking and biorepository operations.
• Cell & Gene Therapy (CGT) Industry Solution Batch of one, patient of one. AI-configured for autologous and allogeneic therapies. Unified with LIMS, MES, and QMS. Targeted at cell and gene therapy developers and manufacturers.
• Medical Device Industry Solution ISO 13485, EU MDR, and FDA 21 CFR 820 support from design controls through post-market surveillance. Targeted at medical device manufacturers.
• Biotech Startup Industry Solution R&D flexibility with GMP compliance and no migration. Targeted at early-stage biotech startups.
• CDMO Industry Solution Per-client data isolation without vendor consultants; AI-configured blueprints per client. Unified with MES, LIMS, and QMS. Targeted at contract development and manufacturing organizations.
• 503B Compounding Facility Industry Solution Pharmaceutical-grade batch records and environmental monitoring trending for FDA-registered 503B outsourcing facilities. Targeted at 503B compounding facilities.

Quantifiable outcome

• Paradromics: −90% less time on traveler review
• +4 more outcomes

Named customers8 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration7 records

AI capability10 records

Feature5 records

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• MasterControl: Long-standing GxP-focused platform for QMS, document control, training, and manufacturing execution in life sciences. Competes most directly with Seal's QMS, MES, and document management blueprints in regulated manufacturing environments.
• Dotmatics: Scientific R&D informatics platform offering ELN, LIMS, and data management for life sciences. Directly comparable to Seal's ELN and LIMS modules, especially in pharma R&D.
• LabVantage Solutions: Enterprise LIMS provider with strong pharma, biotech, and clinical lab penetration. Competes with Seal's LIMS blueprint and adjacent modules, particularly for established mid-market and enterprise QC labs.
• Genedata: Biopharma R&D informatics platform for biologics, cell & gene therapy, and genomics workflows. Overlaps with Seal's biotech and CGT industry solutions for R&D-stage customers.
• STARLIMS (Abbott Informatics): Established LIMS provider (formerly owned by Abbott) serving clinical, life sciences, and manufacturing labs. Competes with Seal's LIMS blueprint, particularly for regulated QC labs.
• Sapio Sciences: LIMS, ELN, and scientific data management platform with strong life sciences and clinical diagnostics focus. Closely comparable to Seal's LIMS, ELN, and SDMS blueprints for biotech and diagnostics customers.
• Benchling: Cloud R&D platform spanning ELN, LIMS, and molecular biology workflows for biotech and pharma. Closest peer in terms of AI-modernized life sciences R&D, and a competitor to Seal's ELN and LIMS modules, especially for biotech customers.

Emerging players

• Arxspan (Bruker): Cloud-based ELN now part of Bruker, serving pharma and biotech R&D. Comparable to Seal's ELN blueprint as a competing notebook solution for life sciences R&D teams.

Broad incumbents

• Veeva Systems: Largest cloud software provider dedicated to life sciences, offering Vault-based QMS, eDMS, CTMS, EDC, eTMF and regulatory solutions across pharma and biotech. Direct competitor to Seal across the GxP compliance stack, with far greater scale and an entrenched validated install base.
• Dassault Systèmes BIOVIA: Enterprise scientific informatics suite from Dassault Systèmes covering ELN, LIMS, QMS, and molecular modeling for life sciences and chemicals. Competes with Seal across the full regulated R&D-to-manufacturing stack as part of a much broader portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/seal-run

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Seal