Your partner in bringing innovative healthcare solutions to life.
Where healthcare innovation intersects with improved patient outcomes
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Your partner in bringing innovative healthcare solutions to life.
Our Consulting Services
Program & Technical Project Management
Effective program and technical management is crucial to successfully advancing health innovations in drug, medical devices, software as a medical device (SaMD), and digital therapeutics development. Learn how Innovenn’s team can help.
Drug Development Consulting
With 300+ IND, NDA, 510(k), De Novo, and PMA submissions, we’ve helped get new drugs, devices and medical software devices (SaMD) into providers hands to improve patient outcomes.
Our consultants will help get your new drug approved by the FDA.
Medical Device Development Consulting
From pre-submission preparations to successful marketing of medical devices, we’ll guide you through the complex approval process for new medical devices.
Software as a Medical Device (SaMD) Development
To optimize patient care and improve outcomes, Innovenn works to build patient-centered SaMD digital health solutions. With more than 125 years of combined expertise, we provide a potent mix of abilities and skills to design, develop, validate, and secure regulatory approvals for innovations that enhance patient health.
Regulatory Planning and Submissions Consulting
A successful regulatory strategy is one that aligns not only with the requirements for data evidence to secure approval but is also integrated with the business, clinical and commercial strategies for positioning the product in the target markets.
Quality Management Systems Consulting
The highest standards must be maintained during medical device research, development, manufacturing, and testing to ensure optimal patient care and assistance. This goal of patient care is governed by quality standards which can be implemented with a robust quality management system (QMS).
Specialized Life Sciences Consulting
Our network of seasoned consulting professionals have extensive experience in the pharmaceutical, medical device, and SaMD space. Our Subject Matter Experts (SMEs) can assist with strategic development, regulatory guidance, and other specialized support to align with your unique requirements and corporate goals.
