Our Mission

We support Medtech and Biopharma innovators with strong, collaborative partnerships, tailored regulatory consulting and writing services, and deep strategic expertise.‍
A new discovery is just the beginning. The spark of a great idea—that’s the easy part. It takes a steadfast team to advance a product from bench to bedside, and keep it there. And like any journey worth taking, there are obstacles along the way.

Solutions to regulatory hurdles and workflow challenges are what GLOBAL lives and breathes. By tapping our collective intelligence and proprietary AI technology, we meet our clients where they’re at with the highest quality deliverables. And we do it with the artful efficiency that only an authority in the industry could provide.

The odyssey of your product is anything but simple, but GLOBAL holds the map to its success. Whether you’re two scientists and a molecule or a leading-edge corporation, we help you navigate with matchless speed and ease.

Our compass is integrity. Our north star is your solution.

We’re the next step on your product’s journey. Let’s transform complexity into simplicity, requirements into compliance, and uncertainty into confidence.

Our Core Values

Integrity

Integrity is how we earn your trust and holds us to high standards for our work and ourselves.

Inclusivity

We believe that our diversity of backgrounds and experience makes us better at the work we do.
‍

Agility

We adapt to change and challenges with agility and creative solutions, because every day matters to patiens who are waiting.

Sanctuary

GLOBAL is a place of sanctuary, where a safe and supportive environment inspires the well-being of our team and clients.

Collective Intelligence

We synthesize the varied experience across our teams to deliver optimized solutions to our clients.

Curiosity

We are lifelong learners with curiosity as the drive behind our everyday innovation, progress, and enthusiasm.

Meet the Executive Team

Emily Stephens, MSC

Founder

Matt Longhurst, JD

CEO

Craig Claussen, PhD, RAC

Senior Director, Regulatory CMC

Sarra De Valence, PhD

VP, Medical Device and Operations

Thomas Stone, JD

VP of Marketing

Jeff Moore, MSC

Associate Director, Clinical

Wendy Bird

Sr. Business Manager

Tim Nally, JD

Corporate Counsel

What Our Clients Say

"The team at GLOBAL is a pleasure to work with, and the quality of their work is of the highest caliber.
‍
GLOBAL truly understood the requirements of our project and the context within which we operate. They assembled a team with exactly the expertise we needed and provided critical contributions from the very first conversation. I was also impressed at GLOBAL's ability to contribute at both the tactical and strategic level. In previous experience, I found firms that provided one or the other, but not both. It was extremely valuable for our project to work with a group that could assist with the details while also keeping view of the overall strategy, and shift back and forth as the submission evolved."

"I have known Em and the team at GLOBAL for several years and the projects that they have supported keeps surpassing my expectations. From day 1, whether it was a single CER or a package of projects, the team at GLOBAL showed up prepared, knowledgeable and dedicated to providing the highest quality within the time frame needed. When we experienced competing priorities within the program or where we weren't certain how to incorporate MDD/MDR lessons learned, GLOBAL proactively brought solutions to the table. Each individual there that I have worked with over the years has approached their project(s) with a true sense of partnership and desire to do what was in the best interest of my team/company.

As for Em, I can't say enough good things about her. Not only does she do a fantastic job steering the company, she does what is right for her employees and she is constantly thinking about how to improve the world around her. Every conversation that I've had with her has been a joy; she's energetic and embodies a positive can-do attitude."

"Really wanted to give a shout out to all of you - I know some of this is completely thankless work, so I wanted you all to know how much I appreciate the efforts. The documents are really in fantastic shape. We're making headway closing/locking up at a fast clip, and it really is thanks to your organization, diligence, and utter setup for [our] success in our final days leading up to publishing. So - thank you...!"

"We really couldn't have done it without you, and certainly not within our extremely aggressive timelines!"

"I am blown away at the work product you provided. This is some of the best RA work I have seen in a very long time!!!!!!!"‍

"Our company has benefited from GLOBAL's services since the end of 2017 and the provision of these services has been instrumental to the success of our company. Based on our experience, what sets GLOBAL apart are the following attributes:

1) Depth of technical expertise
2) Work flexibility and responsiveness
3) Cretive contracting and solutions

In summary, I wholehearedly recommend their services."

"I wanted to offer my sincere and heartfelt thank you for your excellence."‍

"Awesome decision making along the way, super collaborative. Well done."‍

"Thank you and admiration for the incredible team you've assembled - this success is as much your success as it is our success!"