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.
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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

Associated Regulatory Submissions

250 +

Successful Projects

200 +

Product types

90 %

Audits cleared

100 +

Global Clients

Our Expertise

Popular Clients

We’ve 200+ Global Premium Clients

Looking For Regulatory Assistance?

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

Associated Regulatory Submissions

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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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.

Client Testimonials

What Our Clients Say About Us?

FAQs

Frequently Asked Questions!

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

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.