Understanding FDA Pre-Submissions
The FDA Pre-Submission (pre-sub) program is a game-changer for medtech and pharma companies. It allows you to get valuable feedback from the FDA before your actual submission – it’s like
GLOBAL MEDTECH & BIOTECH CONSULTING FIRM
We Drive Commercial Success for Emerging MedTech & Pharma at Startup-Friendly Rates
We expedite product launches and market adoption for companies at any stage, through comprehensive expertise in clinical, regulatory, and business management.
WHAT SETS US APART
Commitment to speed, unwavering compliance, and financial adaptability
The median costs of getting a new device into the U.S. market is $30M. Developing new products is expensive and time-consuming.
Our strategies are proven to decrease your time to market, which can reduce your overall commercialization cost by at least 40%, and ensure you operate within your planned budget
It all starts with a FREE DISCOVERY CALL.
Medtech Strategy
Accelerate the development of your medical device from concept to clinical trials, through regulatory approval.
Clinicial Research
Develop and execute your clinical trials with proven methodologies to optimize operations for study success, from start up to closeout.
Fractional Leadership
Tap into industry experts to drive your strategic objectives by leveraging tenured experience to stay ahead with cutting-edge standards.
OUR CLIENTS
Medical Device Companies
Pharmaceutical Companies
Venture Capital Firms
Accelerators & Incubators
OUR SERVICES
Global Regulatory (FDA, EU MDR, Health Canada)
Clinical Trial Design & Execution
Commercialization Roadmapping
Fractional Leadership
TESTIMONIALS
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