Bioexcel

What Bioexcel does

Bioexcel is a privately held, India-based (Nagpur, Maharashtra) contract research organization (CRO) founded in 2020 that operates exclusively in the medical device and in vitro diagnostic (IVD) vertical — distinct from generalist CROs serving pharma. The company delivers end-to-end clinical and regulatory services for Class I, IIa, IIb, and III medical devices and IVDs across EU MDR, EU IVDR, US FDA (510(k)/De Novo/PMA), India CDSCO, and UKCA/MHRA frameworks, including Clinical Investigations (ISO 14155), Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), PMCF and post-market studies, and Real-World Evidence generation. Its therapeutic area coverage spans cardiology, orthopedics, neurology, oncology, ophthalmology, and other device segments.

The company's core technology consists of two proprietary SaaS-based digital compliance platforms: VigiX™ for materiovigilance and post-market surveillance automation (covering complaint handling, FSCA management, signal detection, and CDSCO/MvPI template generation, with 21 CFR Part 11 and ISO 13485 alignment), and Xceltrials™ for clinical evidence and study operations management. A specialized VigiX layer is positioned as India's first integrated MDR 2017/MvPI materiovigilance automation platform. These platforms are intended to replace manual spreadsheet-based compliance workflows with audit-ready, regulator-aligned digital workflows.

Bioexcel's revenue model is hybrid: professional services revenue from CRO engagements (Clinical Investigations, CER/PER, Regulatory Affairs consulting) and recurring subscription/licensing revenue from the VigiX™ and Xceltrials™ platforms. Pricing is quote-based and tailored to each engagement; no public pricing exists. The go-to-market is sales-led, enterprise-focused, and consultative, using content marketing (regulatory blog, case studies) and direct outreach CTAs (free regulatory consultations, MDR/IVDR gap reviews) to acquire medical device and IVD manufacturers globally. The company claims 100+ projects across 20+ countries, with one founder (Amandeep Kaur, Founder and Managing Director), 11–50 employees, and no disclosed external funding.

Name

Bioexcel

Legal name

Bioexcel

Website

https://bioexcelife.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Bioexcel is a privately held India-based MedTech CRO specializing exclusively in medical devices and IVDs, delivering clinical investigations, CER/PER, PMCF, and regulatory submissions across EU MDR, IVDR, FDA, CDSCO, and UKCA, supported by proprietary VigiX™ and Xceltrials™ digital compliance platforms.

Ownership category

akta.pro rank

Product category

Medical Device CRO Services

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

Keywords

• Medical device CRO
• Clinical investigation services
• Regulatory affairs consulting
• Post-market surveillance
• Digital compliance platform

Headquarters

HQ city

Nagpur

HQ country

India

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CRO Clinical Services: Fee-for-service clinical research organization services including clinical investigations (ISO 14155), Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), PMCF & post-market studies, and Real-World Evidence generation for medical devices and IVDs.
2. Regulatory Affairs Services: Strategic regulatory planning, technical documentation preparation, and global submission management for EU MDR, IVDR, US FDA (510(k)/De Novo), CDSCO, UKCA, and global regulatory frameworks. Revenue generated through consulting engagements.
3. Digital Compliance Platform (VigiX™ & Xceltrials™): Subscription-based or licensing revenue from the company's proprietary digital compliance platforms that automate PMS, vigilance reporting, clinical trial documentation, and regulatory reporting. These are sold as technology-enabled compliance solutions to medical device and IVD manufacturers.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Bioexcel is a specialized Medical Device & IVD Contract Research Organization (CRO) that delivers end-to-end clinical and regulatory services for medical device manufacturers across the product lifecycle. The company supports EU MDR/IVDR clinical investigations (ISO 14155), Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), PMCF and post-market studies, real-world evidence generation, and global regulatory submissions (FDA, CDSCO, UKCA). It complements these services with proprietary digital compliance platforms (VigiX™ for materiovigilance/PMS and Xceltrials™ for clinical evidence management) that automate vigilance reporting, complaint handling, and audit-ready documentation.

Product overview

Bioexcel offers a platform-plus-modules portfolio centered on digital compliance solutions for medical devices and IVDs. The core digital compliance platform consists of Vigi X™ (for materiovigilance and post-market compliance) and Xceltrials™ (for clinical evidence and study operations). VigiX represents a specialized automation layer within the Vigi X™ ecosystem, offering India-specific compliance features including automated adverse event reporting, FSCA management, and CDSCO/MvPI template generation. The portfolio also encompasses clinical and regulatory service offerings including EU MDR/IVDR Clinical Investigations, CER/PER preparation, PMCF studies, regulatory affairs, technical and quality services, and toxicology services.

Differentiator

Problem solved

Functional benefit

Brands

• Vigi X™: Materiovigilance and post-market surveillance digital compliance platform
• Xceltrials™

Products and services

• Vigi X™ Audit-ready automation platform for PMS, vigilance reporting, signal detection, FSCA management, complaint handling, and regulatory reporting under EU MDR, IVDR, and global regulations. Includes QR-based complaint capture, automatic event classification, built-in RCA tools, trend analysis dashboards, and auto-generation of MvPI & CDSCO templates. Targeted at medical device and IVD manufacturers.
• Xceltrials™ Structured clinical investigation and evidence management platform enabling audit-ready clinical trial documentation, evidence tracking, and regulatory reporting for medical device manufacturers.
• Clinical & CRO Services End-to-end clinical evidence generation services including EU MDR Clinical Investigations (ISO 14155), Clinical Evaluation Reports (CER), IVDR Performance Evaluation Reports (PER), PMCF strategy, and Real-World Evidence studies. Targeted at medical device and IVD manufacturers.
• Regulatory Affairs Services Strategic regulatory planning, technical documentation preparation, and global submission management for EU MDR, IVDR, US FDA (510(k)/De Novo), CDSCO, and UKCA frameworks. Includes device classification, licensing, and post-approval support for Class I, IIa, IIb & III medical devices and IVDs.
• Technical & Quality Services Regulatory-aligned technical documentation, risk management (ISO 14971), GSPR mapping, biological evaluation, and quality system documentation support to meet EU MDR, IVDR, and global medical device requirements.
• Toxicology Services Medical device toxicology services including nitrosamine risk assessment and control, extractables and leachables risk assessment, cleaning validation and cross-contamination control, and PDE/OEL/CLP regulatory compliance support.

Quantifiable outcome

• VigiX platform reduces materiovigilance workload by 60–70% while improving compliance accuracy by 95%
• +1 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Parexel: Parexel is a major global CRO with medical device clinical and regulatory services. As a broad incumbent it targets the same enterprise MedTech manufacturers as Bioexcel, particularly for large EU MDR and FDA programs.
• Charles River Laboratories: Charles River is a large contract research organization with medical device testing, safety assessment, and regulatory services. Its broader scientific services portfolio competes with Bioexcel's toxicology, biological evaluation, and quality assurance offerings.
• Medpace: Medpace is a global CRO with a dedicated medical device and diagnostics division. As a broad incumbent, it competes for multi-jurisdiction device clinical investigation and regulatory programs that Bioexcel also serves.
• ICON plc: ICON is a top-tier global CRO with significant medical device and diagnostics capabilities. As a broad incumbent it competes for enterprise MedTech clinical and regulatory work that Bioexcel also pursues.
• IQVIA: IQVIA is the world's largest CRO with a dedicated medical device and diagnostics practice alongside its dominant pharma business. As a broad incumbent, it competes for large enterprise MedTech CRO engagements that Bioexcel targets, but with a much wider portfolio.

Direct peers

• ClariMed: ClariMed is a medical device and IVD-focused human factors, regulatory, and quality services firm. Its device-only specialization and regulatory/compliance services overlap with Bioexcel's clinical evidence and post-market offerings.
• NAMSA: NAMSA is a global, pure-play MedTech CRO offering medical device testing, regulatory, and clinical research services. It is the closest direct competitor to Bioexcel in exclusive medical-device CRO focus, with similar end-to-end clinical, regulatory, and quality service lines.
• Emergo by UL: Emergo by UL is a regulatory consulting business focused on medical devices and IVDs, covering EU MDR/IVDR, FDA, and global market access. Direct overlap with Bioexcel's regulatory affairs and submission services for device manufacturers.
• Qserve Group: Qserve is a specialized MedTech regulatory affairs and quality compliance consultancy supporting EU MDR, IVDR, FDA, and global submissions for medical device manufacturers. Its device-only specialization and regulatory focus mirror Bioexcel's positioning.
• RQM+ (a UL Solutions company): RQM+ is a MedTech-focused regulatory and quality consulting firm serving medical device and IVD manufacturers across EU MDR, IVDR, FDA, and global pathways. Overlapping offerings in regulatory strategy, clinical evaluation, and post-market activities make it a direct peer to Bioexcel.

Market position

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/bioexcelr
• Facebookfacebook.com/61552618430830
• LinkedInlinkedin.com/company/bioexcelife

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

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 Bioexcel