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Accelerating Medical Device Innovation, Globally.
At Bioexcel, we partner with medical device and IVD companies to navigate the complex journey from prototype to regulatory approval with confidence. As a global Clinical Research Organization (CRO), we specialize in EU MDR, IVDR, US FDA, and CDSCO compliance — providing tailored solutions that meet the highest standards in safety, performance, and post-market surveillance.
Whether you’re launching a new device or updating your technical documentation, Bioexcel supports you every step of the way — from clinical investigations, PMCF planning, and CER/BER development to materiovigilance and ISO 13485 QMS implementation.
We’re also the creators of XcelTrials – a purpose-built EDC platform that streamlines PMCF, PMS, and regulatory documentation with real-time insights and global compliance tracking.
Company Details
- Employees
- 31
- Founded
- -
- Address
- Plot No. 24, Vaibhavanand Society, Ganapati Nagar, Zingabai Takli, Nagpur,maharashtra 440030,india
- Industry
- Research Services
- Website
- http://www.bioexcelife.com
- Keywords
- Clinical Investigations (ISO 14155), EU MDR & IVDR Compliance, Post-Market Clinical Follow-up (PMCF), Clinical Evaluation Reports (CER), Biological Evaluation Reports (BER), Regulatory Strategy for CE Marking & US FDA, CDSCO Registration & Test License (India), ISO 13485:2016 QMS Implementation & Audit Support, Risk Management (ISO 14971), Materiovigilance & PMSR Development, Literature-Based Performance Evaluation, Custom Protocol Design & CRO Services, EDC Software for Clinical Trials – XcelTrials, Notified Body & Ethics Committee Liaison, Startup Regulatory Support & Technology Transfer.
- HQ
- Nagpur, Maharashtra
- Competitors
- BioExcel LLC, CURO BIOSCIENCES PRIVATE LIMITED, BioExcel CoE, Avanvi Research and Technologies Pvt Ltd, Clinical Research Management (CRM) Network, Hector Research and Archival Private Limited | Site Management Organization (SMO), Cliantha Research Limited, Canvass Clinical Research Services Pvt.Ltd | Site Management Orgnization ( SMO)| Research institute, ClinTrek Research Pvt. Ltd. & ClinTrek Research LLC, KV CLINICAL RESEARCH PVT LTD( Site Management Organization).
Bioexcel Questions
Bioexcel's website is http://www.bioexcelife.com
Bioexcel's LinkedIn profile is https://in.linkedin.com/company/bioexcelife
Bioexcel has
31 employees.
View email and phone details for 31
employees at Bioexcel.
Bioexcel's industry is
Research Services
Bioexcel's top competitors are
Bioexcel Llc,
Curo Biosciences Private Limited,
Bioexcel Coe,
Avanvi Research And Technologies Pvt Ltd,
Clinical Research Management (Crm) Network,
Hector Research And Archival Private Limited | Site Management Organization (Smo),
Cliantha Research Limited,
Canvass Clinical Research Services Pvt.ltd | Site Management Orgnization ( Smo)| Research Institute,
Clintrek Research Pvt. Ltd. & Clintrek Research Llc,
Kv Clinical Research Pvt Ltd( Site Management Organization).
Bioexcel's categories are Research Services
Bioexcel's founding year is 2020
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Top Bioexcel Employees
-
Sony Kolhe
Clinical Studies I Pmcf I Iso 13485 :…
Contact Info, United States -
Akash Kapse
Project Manager At Bioexcel…
Wardha, Maharashtra, India, India -
Tushar Sarve
Clinical Project Manager &…
Nagpur, Maharashtra, India, India -
Mamta Marbate
Software Developer
Nagpur, Maharashtra, India, India
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