Veranex

What Veranex does

Veranex is a privately held, Raleigh-headquartered medical technology services platform founded in 2021 that operates the industry's first integrated Innovation CRO (iCRO), unifying product design, preclinical research, clinical research, regulatory consulting, quality consulting, and commercialization under a single engagement model. The platform is composed of acquired entities including Ximedica, Quartesian, Boston Healthcare Associates, Experien Group, IMMR, Worrell, Medidee, Fusion Biotec, T3 Labs, and HORUS Scientific, with sub-brand Veranex Biopharma extending into biopharma clinical trials. Underlying technical capabilities include GLP and non-GLP preclinical studies, advanced cardiovascular surgical models (including TAVR landing zone development) performed at purpose-built facilities in Atlanta (33,000 sq ft) and Paris, integrated histopathology, Aquilion Prime SP and GE LightSpeed VCT 64-slice imaging, ISO 13485-certified quality management, and dedicated regulatory practices for FDA, EU MDR, IVDR, and EU Authorized Representative services across cardiovascular, IVD, neurology, ophthalmology, and regenerative medicine therapeutic areas.

The company is backed primarily by Summit Partners, with additional strategic capital from Accelmed Partners II and Lauxera Capital Partners. Veranex sells professional services through direct enterprise sales and website-based project requests to medical device and IVD developers ranging from startups to large established manufacturers, and also serves CROs and life sciences companies with SAS programming and clinical data management services. Pricing is custom and quote-based on a multi-year contract cadence, consistent with B2B professional services. The company operates approximately 15 international hubs across the U.S., U.K., France, Switzerland, Germany, Sweden, Ukraine, and India, employing an 800+ cross-disciplinary expert bench that has supported 700+ clients and 1,000+ programs.

Revenue is not publicly disclosed and the company remains in active growth mode, with no identified IPO or secondary market transaction. Recent operating actions include the November 2025 appointment of a former U.S. FDA physician as Chief Medical Officer and ongoing platform consolidation through targeted acquisitions. Competitive positioning rests on offering a single accountable partner across the entire medtech development lifecycle, thereby reducing vendor hand-offs, redundant testing, and regulatory friction for clients.

Name

Veranex

Legal name

Veranex

Website

https://veranex.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Veranex is a privately held, Raleigh-headquartered Innovation CRO providing integrated design, preclinical, clinical, regulatory, quality, and commercialization services to medical device and IVD developers worldwide, supported by Summit Partners and operating 15 international hubs with 800+ cross-disciplinary experts serving 700+ clients.

Ownership category

akta.pro rank

Product category

Medical Device Contract Research Organization Services

NAICS

Scientific Research and Development Services (5417), Surgical and Medical Instrument Manufacturing (339112)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ), DTx/SaMD Deployment, Integration & Reimbursement Enablement (HLACANAO)

Keywords

• Medical device development
• Preclinical contract research
• Medtech regulatory consulting
• Clinical research organization
• Medtech commercialization services

Headquarters

HQ city

Raleigh

HQ country

United States

HQ region

North America

Offices12 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Medical Device Development Services: Comprehensive professional services for medical device and IVD development including design, engineering, regulatory consulting, quality management, preclinical studies, clinical research, and commercialization support. Revenue is generated through project-based consulting fees and service contracts.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Veranex is an integrated Innovation CRO (iCRO) that delivers concept-through-commercialization services for medical device and in-vitro diagnostic (IVD) companies. Its offering unifies product design and engineering, GLP/non-GLP preclinical and pathology studies, clinical trial execution, regulatory and quality consulting, and market access and commercialization support under a single contract.

Product overview

Veranex is an Innovation CRO (Contract Research Organization) offering an integrated medtech product development platform that unifies design, preclinical, clinical, regulatory, quality, and commercialization services under one roof. The platform consists of core service lines including Design & Development Services, Preclinical & Pathology Services, Clinical Research (CRO) Services, Regulatory Consulting Services, Quality Consulting Services, and Commercialization Services. These are complemented by specialized solutions such as Biocompatibility, Digital Health, Medical Device Consulting, Technical Writing, Testing Solutions, and Training Curriculum. The company also maintains therapeutic area expertise in Cardiovascular, In-vitro Diagnostics, Neurology, and Ophthalmology. A sub-brand, Veranex Biopharma, extends services to biopharma clinical trials. Veranex operates through 15 international hubs across the U.S., Europe, and India, with approximately 800 cross-disciplinary experts supporting over 1,000 programs accelerated and 700 global clients.

Differentiator

Problem solved

Functional benefit

Brands

• Veranex Biopharma: Next-generation biopharma solutions and clinical trials support service offering.

Products and services

• Design & Development Services

Quantifiable outcome

• 1000+ programs accelerated across design to commercialization
• +4 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• NAMSA: NAMSA is the longest-standing medtech-focused CRO offering preclinical, clinical, regulatory, and quality services across the full device and IVD lifecycle. It is the closest direct competitor to Veranex's iCRO model, with comparable therapeutic-area breadth and a similar integrated-service value proposition.
• Qserve Group: Qserve is a medtech-focused regulatory, clinical, and quality consultancy with deep EU MDR/IVDR expertise. It directly overlaps with Veranex's regulatory and quality consulting practice and is a frequent substitute for European medtech clients.

Broad incumbents

• WuXi AppTec: WuXi AppTec is a global CRO/CDMO providing preclinical, clinical, regulatory, and testing services across pharma, biotech, and medical devices. It is a broader incumbent with overlapping preclinical and regulatory capabilities that competes for medtech-services contracts at global scale.
• Charles River Laboratories: Charles River is a large CRO/CDMO with a leading preclinical and discovery-services platform that competes with Veranex's GLP preclinical and surgical-model offerings. It brings substantially greater scale and a broader pharma/biotech customer base.
• IQVIA: IQVIA is the largest global CRO with deep clinical operations, real-world evidence, and technology platforms. It competes for enterprise medtech CRO engagements where scale, data infrastructure, and geographic reach matter most.
• ICON plc: ICON is a top-three global CRO with significant medtech and IVD clinical research capability following its PRA Health Sciences combination. It competes directly with Veranex's clinical research services for larger device sponsors.
• Medpace: Medpace is a mid-to-large CRO with strong full-service clinical operations across multiple therapeutic areas including medical devices. Its operating model and reputation for execution are benchmarks Veranex is measured against.
• Fortrea: Fortrea is the post-spin clinical development services business of Labcorp, providing CRO services with overlap to Veranex's clinical research and biostatistics/data-management offerings. It is a scaled alternative for enterprise medtech sponsors.
• Eurofins Scientific: Eurofins is a global testing-services platform with substantial medical-device testing and IVD laboratory capabilities. It competes with Veranex's biocompatibility, testing, and IVD validation services and offers broader geographic lab coverage.
• TÜV SÜD: TÜV SÜD is a global testing, inspection, certification, and Notified Body organization with deep medtech regulatory and quality expertise. It is a key alternative for device makers seeking EU MDR/IVDR Notified Body and quality system support that Veranex also provides.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/VeranexSolution
• YouTubeyoutube.com/veranex
• Facebookfacebook.com/veranex
• LinkedInlinkedin.com/company/veranex
• Instagraminstagram.com/veranex

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries10 records

Funding overview

Funding rounds2 records

Investors3 records

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

M&A15 records

Investments

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

Frequently asked questions about Veranex