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A Trusted Regulatory and Quality Compliance Partner for Your Biologics Products!

We, at Elexes offer a complete range of regulatory & quality compliance support to companies creating biologics or biosimilar products. From pre-market to post-market, our experts will support you throughout the lifecycle of your product development.
Let’s talk how we can help!
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50+
Years Of
Collective Experience

250 +

Successful projects

200 +

Experience Team

100 +

Global Clients

About Elexes

A Trusted Biologics Regulatory & Quality Compliance Consultant

Elexes has been a trusted name among the best biologics regulatory and quality consultants. Over the years, we have helped top companies to get their product approved in the desired markets. With a team of experienced biologics regulatory consultants, we have managed to become the go-to agency for many biologics product development companies all around the globe for several services like regulatory approvals, regulatory due diligence, clinical trial documentation, quality management in biologics industry (QMS system support), and more...

Our expertise in providing end-to-end solutions from the biologic product development stage, regulatory approvals to product launch & beyond (Post-market surveillance) makes us stand out among other regulatory and quality consulting agencies across the world

More About Us

Associated Regulatory Submissions

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250 +

Successful Projects

200 +

Product types

90 %

Audits cleared

100 +

Global Clients

Our Expertise

Popular Clients

We’ve 200+ Global Premium Clients

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Looking For Regulatory Assistance?

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ANDA or 505(b)(2) | Choosing the Right Abbreviated Approval Pathway for Your Drug

Elexes Team
connect@elexes.com
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Associated Regulatory Submissions

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Why Choose Us

In place of Better solutions for your insurance service

Elexes offer complete range of regulatory and compliance expertise, ensuring full support in product development and post-market compliance.

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Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Quick Turn around

Experience timely results with our efficient services.

Confidentiality guaranteed

We offer 100% confidentiality understanding how critical the data is for you.

Client Testimonials

What Our Clients Say About Us?

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Tom Birney

CEO Masterlink, Arizona

“ Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms. “

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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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Daniel Kinsey

President ViDava, Florida

“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. “

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Linda Pan

Sr. Exe Treedental, Hong Kong

“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. “

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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 excelled at regulatory projects, and document control, and grasped our product's nuances quickly. “

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Philip McFerran

MD Blackrock Pharma, England

“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. “

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Samip Shah

VP Regulatory AliveCor, California

“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. “

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Elizabeth W

Owner Liz Inc., Arizona

“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. “

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Kurt Sysock

CEO Radformation, New York

“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation! “

Latest News & Blog

Read Our Latest Articles

Understanding FDA Recalls for Medical Devices 
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Understanding FDA Recalls for Medical Devices 

Elexes Team
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How to Get FDA Approval for Medical Devices?
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How to Get FDA Approval for Medical Devices?

Elexes Team
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A Guide to Training Management for Medical Devices
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A Guide to Training Management for Medical Devices

Team Elexes
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FAQs

Frequently Asked Questions!

Explore the answers to most common questions about Biologics Regulatory services.

Contact Us
What are biologics drug?
A biologic drug is developed using cells from living organisms such as humans, animals, bacteria, and viruses. Through genetic engineering, these cells are modified to target specific molecules in humans that are causing symptoms or disease.
What is the difference between traditional medication & biologics?
Traditional medication is usually made using chemicals whereas biologics drugs are manufactured using cells of living organisms.
What are the requirements for licensing a biologic?
Issuance of a biologics license is a determination that the product, the manufacturing process, and the manufacturing facilities meet applicable requirements to ensure the continued safety, purity and potency of the product.
How long will it take for my drug to get approved?
It usually depends on your regulatory approval preparedness and the regulatory authority’s timeframe set for the particular type of the product.
Do you offer regulatory services in UAE?
Yes, we do. You can check the complete list of countries we serve here.
How Much Experience Our Team Member ?
In Elexes Medical Consulting we have a collective experience of 50+ years in providing regulatory & compliance assistance to all the industries.

Latest Portfolio

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Understanding FDA Recalls for Medical Devices 
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How to Get FDA Approval for Medical Devices?
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Everything to know about JCI Accreditation | Overview, Benefits, How to get one?
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CE Marking Strategy For Medical Devices | (EU CE Mark)
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Do’s and Don’ts in a Quality Audit

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