Veranex
- Company typePrivate
- Founded2021
- HeadquartersRaleigh, United States
- Headcount—
- GTM typeB2B
- OfferingServices
Veranex firmographics
Firmographics- Name
- Veranex
- Legal name
- Veranex Inc.
- Website
- https://veranexsolutions.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Ownership category
- akta.pro rank
Veranex industry classification
Industry- Product category
- Medical Device Contract Research Services
- NAICS
- Scientific Research and Development Services (5417), Management Consulting Services (54161)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industries
- Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL), Healthcare & Clinical Professional Development (CME/CE) (EDAGANAJ)
Keywords
Where Veranex is headquartered
LocationHeadquarters
- HQ city
- Raleigh
- HQ country
- United States
- HQ region
- North America
Offices13 records
Markets served
Veranex business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales
Revenue model
- Professional Services - Medical Device Development: Integrated contract research services for medical device development spanning design & development, preclinical research, clinical trials, regulatory affairs, quality consulting, and commercialization support. Revenue generated through project-based engagements and service contracts with medical technology companies.
- Training and Certification Programs: Instructor-led training programs for FDA inspection readiness, ISO 13485 quality management, MDR compliance, and regulatory affairs certification. Delivered in partnership with TÜV SÜD Academy. Revenue from course fees.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | ISO 13485 Quality Auditor Training - 5-day program with TÜV SÜD Academy certification pathway |
| Other | Multi-year contract | ISO 13485 Quality Representative Training - 5-day module with TÜV SÜD Academy certification |
| Other | Multi-year contract | ISO 13485 Quality Specialist Training - Foundation module for TÜV SÜD certification |
| Other | Multi-year contract | Manager Regulatory Affairs Training - TÜV SÜD Academy certification for European MDR |
| Other | Multi-year contract | MDR Expert Training - TÜV SÜD Academy certification for EU MDR 2017/745 and PRRC |
| Other | Multi-year contract | MDSAP Internal Auditor Training - Single audit program country-specific requirements |
| Other | Multi-year contract | FDA Inspection Readiness & QMSR Training - Virtual training on evolving FDA inspection approach |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels7 records
Veranex product offering
Product offeringCore offering
Veranex operates as an integrated Contract Research Organization (iCRO) for medical devices and in-vitro diagnostics, providing product design and engineering, preclinical and pathology research, clinical trials, regulatory affairs, quality consulting, manufacturing, and market access/commercialization services under a single accountable organization. The company serves medical device innovators, IVD developers, and biopharma sponsors across the full product lifecycle from concept through commercialization.
Product overview
Veranex operates as an integrated Contract Research Organization (iCRO) that unifies multiple specialized services for medical device and in vitro diagnostic development. The company offers a comprehensive suite of services including Design & Development, Preclinical & Pathology, Clinical Research, Regulatory Consulting, Quality Consulting, Commercialization, and Manufacturing Solutions. These services are connected through an integrated model that enables cross-disciplinary expertise from concept through commercialization. The company also offers specialized solutions in Biocompatibility, Digital Health, Technical Writing, and Training Programs, with a dedicated Biopharma sub-brand for pharmaceutical development support. Veranex serves clients across therapeutic areas including Cardiovascular, In-vitro Diagnostics, Neurology, and Ophthalmology.
Differentiator
Problem solved
Functional benefit
Brands
- Veranex Biopharma: Extends the integrated iCRO model to support pharmaceutical and biologics development, offering expertise in clinical research, regulatory strategy, and commercialization for drug and biologic therapies.
Products and services
- Design & Development Comprehensive product design and engineering services for medical device developers spanning research and strategy, product design, software development, engineering and development, testing and prototyping, human factors engineering, and manufacturing solutions.
- Preclinical & Pathology GLP and non-GLP preclinical research services for medical device testing in animal models, including pathology, surgical and bioskills training, cadaver lab, and dedicated preclinical facilities.
- Clinical Research (CRO) Full-service medical device clinical research organization covering trial design, trial management, project management, study monitoring, safety management, data management, biostatistics and programming, data visualizations, and medical writing.
- Regulatory Consulting Regulatory affairs consulting covering FDA device consulting, EU MDR consulting, EU IVDR consulting, and authorized representative services to support medical device and IVD market access.
- Quality Consulting Quality management system consulting for medical device manufacturers including audit and inspection readiness, QMS consulting, design validation and quality, and special process validation.
- Commercialization Market access and commercialization services for medical devices including innovation and strategy, market and customer insights, access and reimbursement, HEOR consulting, and integrated evidence planning.
- Manufacturing Solutions Medical device contract manufacturing services delivered from early development through full commercial builds with scalable production volumes.
- Biocompatibility Testing Biocompatibility testing services for medical devices performed in alignment with ISO 10993 standards.
- Digital Health Solutions Digital health technology consulting and development services for connected medical devices and software-as-a-medical-device (SaMD).
- Technical Writing Medical and regulatory technical writing services for medical devices and in vitro diagnostics.
- Training Programs Professional training programs for medtech professionals including TÜV SÜD certification training, preclinical training, and broader training curriculum covering ISO 13485, EU MDR, FDA inspection readiness, and regulatory affairs.
- Veranex Biopharma Pharmaceutical and biologics development services that extend Veranex's integrated iCRO model to drug development, including clinical research, regulatory strategy, and commercialization support.
Quantifiable outcome
- 1000+ programs accelerated for 700+ global clients
- +3 more outcomes
Companies that use Veranex
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles3 records
Veranex technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Veranex partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered major and core.
- Recross CardiomajorVeranex conducted GLP preclinical studies (28-day and 90-day post-implantation) for Recross Cardio's PFO Sealing Technology. Studies generated safety and performance evidence that supported FDA approval for first-in-human PROTEA-PFO Early Feasibility Study.
- TÜV SÜD AcademycoreTraining partnership delivering certification programs for ISO 13485 quality management (Quality Specialist, Quality Representative, Quality Auditor), MDR Expert certification, and regulatory affairs training. TÜV SÜD provides the exam and certificate pathway while Veranex delivers applied training content.
- Tufts Medical CentermajorClinical trial site for PROTEA-PFO Early Feasibility Study. Dr. Carey Kimmelstiel, Director of Interventional Cardiology and National Co-Principal Investigator, performed the first successful implantation.
Scale indicators9 records
Recent moves6 records
Expansion highlights6 records
Veranex competitors and assessment
Company assessmentDirect peers
- NAMSA: NAMSA is the largest CRO dedicated exclusively to medical devices and IVDs, offering preclinical, clinical, regulatory, and quality consulting globally. It is the closest direct competitor to Veranex's iCRO model in therapeutic focus and integrated service bundle.
- RCRI (Rover Clinical Research International): RCRI is a medical device-focused CRO providing clinical trial management, biostatistics, and regulatory services for cardiovascular and structural heart devices. It is comparable to Veranex in therapeutic focus and integrated device clinical offering.
- Emergo (by UL): Emergo by UL provides regulatory affairs, quality systems, and clinical evaluation consulting specifically for medical devices and IVDs. It overlaps directly with Veranex's regulatory and quality consulting practice and serves similar medtech and IVD clients.
Broad incumbents
- Charles River Laboratories: Charles River is a global, publicly traded CRO with significant preclinical, safety assessment, and discovery services that overlaps with Veranex's preclinical and pathology offerings. It is broader than Veranex but competes for the same device and IVD sponsor preclinical spend.
- IQVIA: IQVIA is the largest global CRO and life sciences technology provider with extensive clinical research, real-world evidence, and regulatory capabilities. While pharma-heavy, it increasingly competes for device and IVD sponsors seeking integrated development services.
- ICON plc: ICON is a major global CRO with strong medical device and diagnostics clinical research capabilities acquired through Symphony Health and other transactions. It competes for the same clinical and integrated development budgets as Veranex.
- Medpace: Medpace is a mid-to-large CRO with a strong therapeutic-area operating model that overlaps with Veranex's therapeutic specialization across cardiovascular, neurology, and ophthalmology device development.
- Parexel International: Parexel is a large global CRO with a dedicated Medical Devices and Diagnostics group offering regulatory, clinical, and market access services. It competes with Veranex for integrated medtech development mandates.
- WuXi AppTec: WuXi AppTec is a global CRO/CDMO with preclinical, clinical, and regulatory services relevant to medtech sponsors operating internationally. It represents a scaled, lower-cost competitor for portions of Veranex's preclinical and clinical work.
Regional players
- DEKRA Certificación: DEKRA is a global testing, inspection, and certification organization with medical device Notified Body services, ISO 13485 certification, and regulatory consulting. It overlaps with Veranex's quality, certification, and EU Authorized Representative services.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks4 records
Key highlights6 records
Customer concentration
Veranex social profiles
Digital presenceVeranex compliance and trust
Trust signalCompliance14 records
Veranex financial estimates
Financial estimateRevenue estimate
Valuation estimate
Veranex leadership team
Management profileNumber of profiles
Profiles14 records
Veranex subsidiaries and ownership
Company hierarchySubsidiaries1 record
Veranex funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Veranex M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Veranex
What does Veranex do?
Veranex operates as an integrated Contract Research Organization (iCRO) for medical devices and in-vitro diagnostics, providing product design and engineering, preclinical and pathology research, clinical trials, regulatory affairs, quality consulting, manufacturing, and market access/commercialization services under a single accountable organization. The company serves medical device innovators, IVD developers, and biopharma sponsors across the full product lifecycle from concept through commercialization.
Is Veranex a public or private company?
Veranex is a private company. It is classified as unknown and is currently operating.
When was Veranex founded?
Veranex was founded in 2021.
Where is Veranex based?
Veranex is headquartered in Raleigh, United States, in the North America region.
How does Veranex make money?
Two revenue lines are on record. Professional Services - Medical Device Development is the primary driver. The others are training and Certification Programs.
Who are Veranex's main competitors?
Direct peers on record are NAMSA, RCRI (Rover Clinical Research International) and Emergo (by UL). Broad incumbents are Charles River Laboratories, IQVIA, ICON plc, Medpace, Parexel International and WuXi AppTec. DEKRA Certificación is listed as a regional player.
Does Veranex have an API?
No public API is recorded for Veranex.
What industry is Veranex in?
Veranex's product category is Medical Device Contract Research Services. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of HLAGAKAL, Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control). Its NAICS code is 5417 and its SIC code is 8731.