What Celegence does

Celegence is a US-headquartered life sciences regulatory solutions provider founded in 2017 and operated as CELEGENCE LLC, delivering consulting services and proprietary technology to pharmaceutical manufacturers and medical device/IVD companies. Its core offering combines SME-led regulatory consulting — covering eCTD submissions, regulatory writing, CMC technical writing, medical writing, RIMS management, regulatory affairs consulting, and regulatory intelligence — with three proprietary technology products: CAPTIS®, an in-house AI platform for automated authoring of EU MDR/IVDR documentation including CERs, PMCF plans/reports, CEPs, PEPs, and SSCPs; Dossplorer™, a cloud-based eCTD viewer and dossier manager acquired from Qdossier in July 2022; and Dosscriber™, MS Word-based eCTD document templates. The technology stack is supported by an engineering and delivery center in Cluj, Romania, while consulting delivery is distributed across offices in the USA (Downers Grove), UK (London), Netherlands (Waalwijk), India (Bangalore), Japan (Tokyo), and Brazil.

The business model blends professional services revenue (project-based and multi-year enterprise engagements) with recurring SaaS subscription access to the CAPTIS platform and technology licensing for Dossplorer and Dosscriber. Pricing is quote-based and not publicly disclosed, with multi-year contract cadences typical for enterprise engagements. Go-to-market is direct enterprise sales targeting regulatory affairs leaders, quality assurance executives, and compliance officers at pharma and medtech manufacturers; named customers include Johnson & Johnson, AstraZeneca, Novartis, Gilead Sciences, Baxter, Cook Medical, Bausch Health, Alcon, Otsuka, Regeneron, and Philips Healthcare. The company holds ISO 9001, 14001, 45001, and 27001:2022 certifications, NMSDC Certified-MBE status (2022), and WBE certification, and maintains a global partnership footprint anchored by premier sponsorship of RAPS US Convergence and active participation in DIA and MedTech Summit industry events.

Name

Celegence

Legal name

CELEGENCE LLC

Website

https://celegence.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

101–250 employees

Short description

Celegence provides tech-enabled regulatory affairs services and compliance technology for pharmaceutical and medical device/IVD manufacturers globally, combining proprietary AI tools (CAPTIS®), cloud dossier management (Dossplorer™), and SME-led consulting across eCTD submissions, clinical evaluation reports, and EU MDR/IVDR compliance.

Ownership category

akta.pro rank

Product category

Life Sciences Regulatory Affairs Consulting and Compliance Services

NAICS

Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)

Keywords

• Regulatory affairs consulting
• Medical device compliance
• Pharmaceutical submissions services
• ECTD publishing solutions
• EU MDR IVDR compliance

Headquarters

HQ city

Chicago

HQ country

United States

HQ region

North America

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting Services: Professional consulting services including regulatory strategy, submissions management, clinical evaluation, and compliance support for pharmaceutical and medical device companies. Services delivered by SMEs with advanced degrees and extensive industry experience.
2. AI Technology Platform Subscription: SaaS subscription access to CAPTIS® AI platform for automated medical writing and documentation. Technology platform enables faster turnaround and reduced compliance burden for clients.
3. Regulatory Technology Tools: Access to proprietary tools including Dossplorer™ for dossier management and Dosscriber™ for document templates. Technology licensing provides ongoing value for regulatory operations.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

Celegence provides tech-empowered regulatory affairs consulting and compliance services to pharmaceutical, medical device, and in-vitro diagnostics manufacturers globally. Its offering combines SME-led regulatory consulting across submissions, clinical evaluation, post-market surveillance, and data governance with proprietary AI-enabled technology platforms (CAPTIS®, Dossplorer™, Dosscriber™) that automate medical writing, dossier management, and eCTD document preparation.

Product overview

Celegence offers a tech-empowered regulatory services platform combining proprietary AI solutions with expert consulting for pharmaceutical and medical device companies. The core platform consists of three main proprietary products: CAPTIS® AI Platform (in-house AI for medical writing and documentation automation), Dossplorer™ Cloud eCTD Viewer & Manager (acquired from Qdossier in 2022), and Dosscriber™ eCTD Document Templates. These technology products are supported by an integrated suite of consulting services spanning regulatory publishing, regulatory writing, CMC technical writing, medical writing, RIMS management, data governance, regulatory affairs consulting, regulatory intelligence, and combination products services. For medical devices and IVDs, services include EU MDR/IVDR consulting, post-market surveillance, PMCF, clinical evaluation reports, systematic literature reviews, US FDA consulting, and technical file/DMR remediation. The company leverages its AI platform to automate complex content authoring processes, enabling faster, higher-quality deliverables with greater transparency and reduced compliance burden.

Differentiator

Problem solved

Functional benefit

Brands

• CAPTIS®: AI-powered regulatory compliance technology platform designed to streamline medical writing and documentation processes for EU MDR/IVDR compliance, including CEP/CER, PEP/PER, PMCF plans/reports, and SSCPs.
• Dossplorer™
• Dosscriber™

Products and services

• CAPTIS® AI Platform

Quantifiable outcome

• 50% faster delivery with intact quality
• +6 more outcomes

Named customers18 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature3 records

Partnerships

One partnership is on record.

• QdossiercoreStrategic or Co-development Partner · 18 July 2022Celegence acquired Qdossier, a provider of document and dossier management services for the pharmaceutical industry. The acquisition included integration of Qdossier's cloud-based technology, Dossplorer, expanding Celegence's technological and consulting offerings worldwide. The integration enables proactive, personalized support for clients in product approval and market maintenance.

Scale indicators11 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• ProPharma Group: Specialist regulatory, medical affairs and compliance consulting firm serving pharma and MedTech — closely aligned service catalog and target customers as Celegence, with a similar mid-sized boutique positioning.
• VCLS (Voisin Consulting Life Sciences): Regulatory and clinical consulting firm specializing in health authority interactions, submissions and clinical evaluation reports — comparable to Celegence's EU MDR/IVDR and pharma regulatory services.
• Pharmalex: Regulatory affairs and pharmacovigilance services provider for pharma and biotech; competes head-to-head with Celegence on EU submissions, CMC writing and regulatory strategy.

Broad incumbents

• ICON plc: Large CRO with dedicated regulatory and medical writing/affairs services, competing for the same pharma and MedTech enterprise clients as Celegence.
• IQVIA: Global CRO and life sciences services giant offering regulatory affairs, eCTD publishing, RIMS, and increasingly GenAI-enabled medical writing — overlaps with Celegence's pharma services but at vastly larger scale and broader portfolio.
• Parexel: Global CRO with strong regulatory consulting, eCTD publishing and clinical evaluation report practices — directly competes for the same EU MDR/IVDR and pharma submission work.
• Labcorp Drug Development (Fortrea): Large CRO with regulatory operations, eCTD publishing and clinical development services — competing for enterprise pharma and MedTech regulatory outsourcing spend.
• Charles River Laboratories: Life sciences services firm with regulatory and safety/medical writing offerings, serving large pharma and medical device manufacturers — adjacent competitor in regulatory services.

Emerging players

• RegDesk: AI-driven regulatory intelligence and submission management platform for MedTech and IVD — emerging tech-native competitor to Celegence's CAPTIS AI and Dossplorer stack.
• MediSpend (Pharmalex) / ArisGlobal: Provider of RIMS, regulatory content management and AI-augmented regulatory workflows — competes with Celegence's Dossplorer/RIMS management and emerging AI capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCryD2QgpDiR4ofZe34J4a3g
• Facebookfacebook.com/celegence
• LinkedInlinkedin.com/company/celegence
• Xx.com/celegence

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments1 record

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

Frequently asked questions about Celegence