Elexes Team 
Team Elexes 
Regulatory | Quality | Compliance
A Trusted Regulatory & Quality Compliance Consultant
Elexes has been a trusted name among the best regulatory and quality compliance consultants. Over the years, we have helped top medical device, pharma, food, and cosmetics companies to get their devices and products approved in the desired markets. With a team of experienced regulatory consultants, we have managed to become the go-to agency for many companies all around the globe for several services like regulatory approvals, regulatory due diligence, clinical trial documentation, QMS system support, and more…
Our expertise in providing end-to-end solutions from the product development stage, and regulatory approvals to product launches & beyond (post-market surveillance) makes us stand out among other regulatory and quality consulting agencies across the world.
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Associated Regulatory Authorities
250 +
Successful Projects
200 +
Product types
90 %
Audits cleared
100 +
Global Clients
Our Expertise
Industries We Serve
Medical Device Regulatory & Quality Compliance
We offer a complete range of medical device regulatory & quality compliance support. From production life-cycle to post-market compliance support, we offer all kinds of regulatory support to medical device companies and manufacturers. Our experts also offer documentation support.
Cosmetic Regulatory & Quality Compliance
From cosmetic product development, cosmetic PIF compliation, cosmetic labeling, documentation, clinical trials, cosmetic product safety report to post-market compliance, we offer regulatory support to cosmetic companies. We have a dedicated team of cosmetic regulatory experts who understand the overall cosmetic regulatory.
Food & Quality Compliance
At Elexes, we have a professional team of regulatory experts who understand the overall process of food product compliance. Be it food labeling, facility inspection, documentation, clinical trials to post-market compliance support, our experts will support you throughout.
Hospital regulatory & Compliance Support
Right from environmental & occupational safety assessment, PSQIA compliance, policies on data privacy and security, HITECH Act compliance to emergency preparedness and disaster planning, we at Elexes offer extensive range of regulatory and compliance assistance to hospitals.
Regulatory & Quality Compliance Consutng
Why Choose Us?
We help manufacturers be compliant to all the regulatory standards and quality standards.
Stay compliant with industry regulations and standards.
Achieve regulatory success with Elexes, all within your budget.
Experience timely results with our efficient services.
We offer 100% confidentiality understanding how critical the data is for you.
Our Team Member
Meet Our Leaders
Parul Chansoria
Founder and CEO
Vivek Goyal
Co-Founder
Dr. Mark Harman
Clinical Advisor
Amit Padhy
Associate Tech Manager
Client Testimonials
What Our Clients Say About Us?
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! 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. “
Linda Pan
Sr. Exe Treedental, Hong Kong
“I’m a fan! 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!
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Tom Birney
CEO Masterlink, Arizona
“Great work! Elexes team gave our organization immense support. Apart from being knowledgeable, and thorough; they were very responsive. All these are excellent virtues that I would look for when choosing a consulting firm.
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They are very 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. “
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They’re always helpful and proactive. They are thorough and have provided invaluable support to us on import, labels, and registrations. “
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Created regulatory-compliant supplement fact sheets for multiple products. Their work helped us to sell within domestic & international markets without any problems. They were accurate and the turnaround time was amazing. “
Kurt Sysock
CEO Radformation, New York
“ Elexes promised and delivered a go-to organization for FDA regulatory and quality systems work. They have outperformed every expectation we had. “
Popular Clients
We’ve 200+ Global Premium Clients
FAQs
Frequently Asked Questions!
Learn what most of our clients ask while taking regulatory and compliance services.
How much will it cost to get support from professional regulatory consultant?
The cost of regulating consulting usually varies as per the Intended market, industry you are in & type of the product. To know more, please connect with an expert at Elexes.
How do regulatory consultant help with product development
Regulatory consultants keep a check for any compliance risks during product development. They also assist you to create the right development strategy in compliance with the regulations of the market you wish to launch your product in.
Is post-market surveillance and vigilance required?
Yes, it helps in assessing your product’s performance post launch and staying compliant with updated regulations.
How long will it take for my product to get approved?
It usually depends on your regulatory approval preparedness and the regulatory authority’s timeframe set for the particular type of product.
How much experience do you have?
In Elexes Medical Consulting we have a collective experience of 50+ years in providing regulatory & compliance assistance to all the industries.
