Pre-clinical Support

It is vital for every Biologics and Drug company to get professional pre-clinical support while keeping an eye on the entire product development process. We, at Elexes have team of experts who will guide you build a pathway to your product launch.

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The good thing about having Elexes at your side while developing biologics or drugs is that we have the expertise at all stages of drug development. Whether you are at the initial development stage or post-approval stage, we can offer you the best support in building and executing a CMC strategy customized to your drug’s unique composition, use, and formulation process.

With us, you can get support for

Our experts will
help you with the following -

Defining regulatory requirements for product (biologics/drug) development and transfers when it comes to manufacturing and control
Defining the content of both analytical and quality control package that i required for clinical trials as well as MAA submission
Supporting the development, qualification, as well as validation of analytical methods
Preparing all the regulatory documentations related to product manufacturing as well as quality
Performing gap analysis -
Reviewing and analysing clinical trial data to optimize the regulatory approach
Supporting scale down models

Looking for Pre-Clinical Support for your Drug or Biologics Product?

If Yes, Simply Get In Touch!

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Client Testimonials

What Our Clients Say About Us?

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. _“

Diane Bryant

CEO Novasignal, Los Angeles

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

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! _“

Joshua Mink

Manager Outset Medical, California

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

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. _“

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If you are among those biologics or drug companies who wish to get best compliance assurance program, all you have to do is contact us and we will assist you through the entire regulatory clearance & approval journey.

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