Veranex
Veranex is a pioneering global MedTech services provider, conceived in 2020 and launched in 2021, that unites design, preclinical, clinical, regulatory, and market access expertise under one integrated platform. Its mission is to accelerate life-changing medical innovations from concept to commercialization, leveraging a purpose-built iCRO model that enhances speed, quality, and strategic alignment across all development phases. With a global footprint, diverse expert teams, and a comprehensive platform, Veranex aims to transform healthcare by delivering innovative, patient-centric solutions faster, safer, and smarter.
Industries
Nr. of Employees
Very Large (1000+)
Products
Point-of-care cartridge-based diagnostic instrument (prototype)
Development and engineering of a prototype cartridge‑based point‑of‑care diagnostic instrument, including industrial design, electrical/firmware engineering, verification builds, and pilot instruments for clinical studies.
Point-of-care host‑response molecular diagnostic test (mRNA panel)
Assay and consumable development supporting a rapid host‑response molecular test designed to indicate likelihood of bacterial vs viral infection and disease severity, developed alongside instrument engineering and clinical validation support.
Point-of-care cartridge-based diagnostic instrument (prototype)
Development and engineering of a prototype cartridge‑based point‑of‑care diagnostic instrument, including industrial design, electrical/firmware engineering, verification builds, and pilot instruments for clinical studies.
Point-of-care host‑response molecular diagnostic test (mRNA panel)
Assay and consumable development supporting a rapid host‑response molecular test designed to indicate likelihood of bacterial vs viral infection and disease severity, developed alongside instrument engineering and clinical validation support.
Services
Product Design & Engineering
Concept generation, mechanical/electrical/firmware engineering, industrial design, DFM and prototype builds to create development‑ready medical devices and diagnostics.
Preclinical Research Services
GLP and non‑GLP study design and execution, surgical and interventional models, pathology support, and facility‑based preclinical testing to support regulatory submissions.
Clinical Research and Trial Management
Protocol development, site and investigator networks, trial execution and clinical operations for device and diagnostic studies.
Commercialization, Market Access & HEOR
Reimbursement strategy, payer research, HEOR modelling, market insight and integrated evidence planning to support launch and adoption.
Regulatory Affairs & Quality Management
Regulatory strategy and submission preparation for FDA and EU pathways combined with QMS consulting, ISO 13485 alignment, process validation (IQ/OQ/PQ) support and audit readiness (mock inspections, gap assessments, MDSAP preparation). Services align quality systems with product development and manufacturing scale‑up.
Pathology and Histology Services
Histopathology protocol execution, tissue processing and microscopic analysis to support preclinical research and regulatory dossiers.
Product Design & Engineering
Concept generation, mechanical/electrical/firmware engineering, industrial design, DFM and prototype builds to create development‑ready medical devices and diagnostics.
Preclinical Research Services
GLP and non‑GLP study design and execution, surgical and interventional models, pathology support, and facility‑based preclinical testing to support regulatory submissions.
Clinical Research and Trial Management
Protocol development, site and investigator networks, trial execution and clinical operations for device and diagnostic studies.
Commercialization, Market Access & HEOR
Reimbursement strategy, payer research, HEOR modelling, market insight and integrated evidence planning to support launch and adoption.
Regulatory Affairs & Quality Management
Regulatory strategy and submission preparation for FDA and EU pathways combined with QMS consulting, ISO 13485 alignment, process validation (IQ/OQ/PQ) support and audit readiness (mock inspections, gap assessments, MDSAP preparation). Services align quality systems with product development and manufacturing scale‑up.
Pathology and Histology Services
Histopathology protocol execution, tissue processing and microscopic analysis to support preclinical research and regulatory dossiers.
Expertise Areas
- Medical device product development
- In‑vitro diagnostic (IVD) development
- Preclinical study design and execution
- Clinical trial management for devices and IVDs
Key Technologies
- Human‑centered design
- Rapid prototyping and DFM
- Embedded firmware and medical device software
- Electronic Data Capture (EDC) and clinical data platforms