Contact
Contact

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!
img
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

IND
NDA
ANDA
OTC
BLA
CPNP

250 +

Successful Projects

200 +

Product types

90 %

Audits cleared

100 +

Global Clients

Our Expertise

Popular Clients

We’ve 200+ Global Premium Clients

Saneso
Niramai
Apex dental sensors
Neurasignal
SS inovations
Amaryllis
Inclode
iMedisync
DJOGlobal logo cmyk_TM
Summus Laser Logo
Saneso
Niramai
Amaryllis
Apex dental sensors
SS inovations
DJOGlobal logo cmyk_TM
Neurasignal
iMedisync
Inclode
Summus Laser Logo

Looking For Regulatory Assistance?

Let's Talk How We Can Help You?

Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img

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

Elexes Team
connect@elexes.com
Read Now

Associated Regulatory Submissions

CPNP
BLA
OTC
ANDA
NDA
IND

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.

img
img
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?

image

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. “

image

Diane Bryant

CEO Novasignal, Los Angeles

“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. “

image

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. “

image

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. “

image

Joshua Mink

Manager Outset Medical, California

“Highly recommend Elexes! They always meet commitments and follow through on action items. “

image

Michal Depa

CTO Jana Care, Massachusetts

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

image

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. “

image

Samip Shah

VP Regulatory AliveCor, California

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

image

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. “

image

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

Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance
Post a Comment

Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance

Team Elexes
Read More
Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies
Post a Comment

Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies

Team Elexes
Read More
FDA Class II medical devices
Post a Comment

FDA Class II medical devices

Elexes Team
Read More

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

VP for Medical Device and IVD companies

Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance
Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies

Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies
FDA II medical devices

FDA Class II medical devices
technological changes that call for new 510(k) submission

Technological Changes that Call for a New 510k Submission
quality management system eQMS

Medical Device Quality Management System | Why Switch to an Electronic QMS?
Post-Market Surveillance For Medical Devices & IVDs

Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection
medical device risk analysis

Medical Device Risk Analysis | How often do you review risks at your company? 
labeling changes that need new 510(k) submission

Medical Device Labeling Changes That Require a New 510(k) Submission
medical device labeling components, types, tips

What is Medical Device Labeling, its Components, Types, and Tips to Simplify the Process?
FDA Recalls

Understanding FDA Recalls for Medical Devices 
FDA approval for medical devices

How to Get FDA Approval for Medical Devices?
medical device training

A Guide to Training Management for Medical Devices
Predicate Device

Predicate Device: What is it and How to Choose the Right One?
Importance of internal audits

The Importance of Conducting Internal Audits in Medical Device Companies
submission 510k submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Need Any Help? Or Looking For an Agent

9806071234
sendmail@example.com
Working Hours : Sun-monday, 09am-5pm
© 2024 Elexes. All Rights Reserved.