Service: REgulatory

New Science Calls for
New Regulatory Strategies

Today's medical products are different.
Why place your trust with consultants stuck in the past?
Find out why after just one meeting,
3 out of 4 people chose to work with us.
Some CROs rely on the number of products
they have worked on in the past
Let’s be honest. Prior experience is rarely kept in an institution. People move. Knowledge is easily drained.
If you are trying to build the next Google, you’re not going to hire the people that built Netscape.

Work with a team that has the technical and regulatory expertise that today's medical products demand.
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
First & Last Name
"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."
Founder & CEO
Robert Whitehead
“Proxima has been such a wonderful help every step of the way. Everyone is truly great to work with.”
Junior Project Engineer
Karen Wells
Proxima has been an important piece of Memgen's regulatory and clinical achievements for multiple years now, playing a vital role in our IND approval, clinical launch, and trial management of our first-in-human study of our lead cancer immunotherapy biologic. Proxima and its growing team have continually shown their experience, broad skill sets, adaptability to our company's needs and objectives, and value in an industry with a myriad of CROs to choose from.
Mark Cantwell
Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium that includes Baylor College of Medicine, Texas Children's Hospital, Texas A&M University, Rice University, University of Houston, and Fannin Innovation Studio. SWPDC is supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.
Chester J. Koh, MD
We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!
Regulatory & QA Manager
Michael Selva
Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.
Jade Doucet-Martineau
We have had the pleasure of working with the Proxima team for over a year on overall regulatory strategy and support for FDA interactions. The entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.
CEO and Co-Founder
Bobby Reddy Jr.
“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”
Marc Bessler, M.D.
"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."
COO & Co-Founder
Geoffrey Lucks

Industry-leading MedTech and Drug Discovery Regulatory Services

Strategy & Submissions
Support from development to launch. Planning and coordinating US/European Medical Device or Drug submissions.
Agency Representation
Representation at meetings can be as important as the submission document. Our professionals have supported hundreds of regulatory meetings with exceptional results.
Human Factors and Usability
Formative and validation testing in a state of the art facility headquartered in the Texas medical center.
Clinical development
Assistance with First in Human Studies, Accelerated POC. Early Phase/Phase 1, Trial Design & Management, Confirmatory Phase IIB – Phase III Studies

Frequently Asked Question

Must an IRB review a study conducted after submission of 510(k) to FDA but prior to FDA’s decision on the submission?
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Investigational New Drug Application (IND)
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Latest INsight

Why Your CRO Should Be With You From Concept to Commercialization
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Latest Video

Applying For a Product Development CPRIT Grant
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Meet your regulatory milestones.
We'll work with you every step of the way.
Engage with a Regulatory expert