How we differ
Every idea is a good idea! What it needs is a strong regulatory, quality, clinical and product partner to get it to the market and keep it there.
We adopt an EFFICIENT APPROACH in everything we do and customize solutions for your company size in a cost effective manner.
Our strengths:
We adopt an EFFICIENT APPROACH in everything we do and customize solutions for your company size in a cost effective manner.
Our strengths:
- Project management
- Execution
- Domain specific expertise
- Effective communication
- Process dependence
About Us
What is Elexes?
- Founded by a team of professionals with over 20 years of experience, Elexes is dedicated towards bringing safe and effective healthcare products to the market and ensuring that the existing ones are in compliance.
- We comprise of professionals who are RAC certified by RAPS, Certified Quality Auditor by American Society of Quality, and Certified Lead Auditors for ISO 13485, cGMP, 14971, and 9001.
- Specializing in Medical Devices, IVD, Combination Products, Biologics and Drugs, 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, product documentation, 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, NDA, IND, BLA, 510k, and offered numerous other regulatory and quality services.
- Get in touch with us and we can address your requirements pertaining to the US, EU, Canada 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.
