Accelerate your market access with regulatory advisory and execution under one roof.
Quality Compliance That Empowers Your Business
- From pre-market entry to post-market success
- Reduced time to market, reduced costs
0
+
Global Clients
0
+
Successful Projects
0
+
Product Types
0
+
Audits Cleared
Our Expertise
Regulatory Approvals
Project Compliance
Clinical Evaluations
Quality Certifications
Why Elexes
Elexes' core has always been regulatory and quality services, unlike other companies in the field who added these over time.
- 15 Years of Experience
- Best pricing in the market
- 100% confidentiality
- ISO 13485 certified
- End-to-end project management
- Extensive knowledge in US FDA, MDR, IVDR, software, and global regulations
Parul Chansoria
Founder and CEO
- MS Bioengineering, UIC Project Management, Stanford University
- Past experience with Stryker, Intuitive Surgical, and several startups
- Certified Quality Auditor by the American Society for Quality, RAC certified by RAPS
Parul, with years of industry experience, has built and trained a diverse team of professionals in biomedical engineering, microbiology, and life sciences to lead every project. Elexes collaborates with Subject Matter Experts to gain deeper insights into specific areas. Our goal is your success!
Don't Just Take Our Word For It
Trusted by hundreds of happy clients
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
Highly recommend Elexes! They always meet commitments and follow through on action items.
Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
Previous
Next
Stay compliant, build trust, and enter the market faster
Clients have rated Elexes as the best in business!
