How we differ
Every idea is a good idea! What it needs is a strong regulatory and quality support to see the light of day. We bring your ideas to the market and keep them there.
We offer the most reasonable pricing
Our strengths:
We offer the most reasonable pricing
Our strengths:
- Project management
- Execution
- Domain-specific expertise
- Effective communication to keep Clients consistently happy
- Adherence to timelines and quality of work
- Integration into your company through Full time equivalent (FTE) services
- All under one roof - Product development, Quality, Clinical, advice and documentation
About Us
What is Elexes?
- Founded by a team of professionals with over 20 years of experience in Regulatory affairs, Elexes is dedicated towards bringing safe and effective healthcare technologies to the market and ensure that the existing devices are in compliance.
- We comprise of professionals who are RAC certified by RAPS, Certified Quality Auditor by American Society of Quality, and Certified Lead Auditor for ISO 13485 by BSI.
- Specializing in Medical Devices, IVD and Combination Products, we have developed into a trusted online partner offering a wide range of compliance and market-access services, with an expertise in regulatory submissions, post market surveillance, clinical writing and quality systems. Over the past years, we have served more than 50 clients, both national and international, assisted with several FDA submissions, CE marks, ISO 13485 certifications, CMDCAS certifications and offered numerous other regulatory and quality services.
- Get in touch with us and we can address your regulatory and quality requirements pertaining to the US, EU, Canada, India and markets all around the world. Let’s work together and give the best to the society!
Elexes team gave our organization great support. Apart from being knowledgeable, and thorough; they were very responsive. All these are excellent virtues which I would look for when choosing a consulting firm.
Elexes should be your next regulatory consultant. A timeline based project plan from their part greatly expedited the process.
Elexes promised and delivered - a go-to organization for FDA regulatory and quality systems work. They have outperformed every expectation we had.
They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports, and provided advice on testing and manufacturing. They are very professional and easy to work with.
We worked with Elexes on import-export regulations, and couldn't have asked for a better expert. Elexes team was very patient in answering all our questions, and guided us on every step. Will definitely work with them again!
They are prompt and responsive and have done a great job with our regulatory projects and document control set-up. They were easy to contact and were quite quick at understanding the nuances of our product. I highly recommend them!
Elexes team are always most helpful and proactive. They are thorough and have provided invaluable support to us on import, labels and registrations.
Created regulatory compliant supplement fact sheets for multiple products. Very happy with the work. They were accurate and the turnaround time was amazing.
