Advancing Drugs and Medical Device Technologies
from Discovery to Commercialization
Regulatory
We offer regulatory affairs services to accelerate product approval by handling the communications and submission for our clients.
Regulatory
We offer regulatory affairs services to accelerate product approval by handling the communications and submission for our clients.
Strategy
Based on the indications and medical claims, we develop an accelerated approval roadmap with our team of experts using an integrated and adaptive approach to commercialization.
Strategy
Based on the indications and medical claims, we develop an accelerated approval roadmap with our team of experts using an integrated and adaptive approach to commercialization.
Clinical
From protocol development to biostatistics and data management, our team is positioned to support all aspects of your clinical trial.
Clinical
From protocol development to biostatistics and data management, our team is positioned to support all aspects of your clinical trial.
Commercialization
Raising funds? We have helped our clients raise over $700M USD of capital over the past decade. Join our innovative community today!
Commercialization
Raising funds? We have helped our clients raise over $700M USD of capital over the past decade. Join our innovative community today!
Management and Strategy
Cross-Functional Services
Project Management
Let us provide an extra pair of hands to move your assets forward. Our team can manage development activities including vendor sourcing, R&D and manufacturing.
Expert Team
Assembling a team of experts can be prohibitively expensive. Let us supplement your team and bring our expertise to keep you on track.
What we do in more detail
%
We maintain a 100% success rate in medical device approvals by the US FDA.
Through our partnering and investor relation programs, we have helped raise over $700M in dilutive capital for our clients.
Over 90 FDA IND, NDA, BLA, and 505(b)2 successful submissions.
Over 250 FDA CDRH medical device successful submissions.
End-to-End Solutions
Our Solutions
Investors
To find your next opportunity, our team can help assess the commercial feasibility of an asset and provide connections to our portfolio companies that align with your investment thesis.
Incubator Offering
Incubators
Inventors oftentimes do not understand how to efficiently convert a research project into a commercial product. Through our Entrepreneurship Bootcamp, our faculty will cover investor preparedness, regulatory strategy, IP protection, among other core pillars of commercial success.
Resources
Request a Regulatory Webinar
Our faculty can provide a complimentary webinar on regulatory strategies for medical devices and therapeutics. Contact us...
Entering the US Healthcare Market
The US healthcare market is a complex, fragmented space. Our guide and checklist will facilitate a soft-landing to help...
FDA EUA Premarket Submissions
The White House's recent announcement that the Biden Administration plans to end the public health emergency on May 11th,...