CONSULTING SERVICES

Decreasing go-to-market times for lifescience companies

Extremely knowledgeable on regulatory regulations

Insulet Corporation
Wonderful at explaining and tailoring their approach to our needs

Maternal Microbiome Clinical Trial
We feel great about the results and milestones that we have accomplished

Long Island University

Bringing deep experience to Scientific, Regulatory, and Product Development consulting services

We provide global regulatory strategy, submission development, and clinical trial coordination for biotech, device, diagnostic, and pharma products, working with international health authorities such as FDA, Health Canada, MHRA, ANVISA, PMDA, CFDA, and KFDA.
We conduct scientific research feasibility studies, develop pre-clinical safety evaluations, and provide technical and CMC documentation for design, patent, and regulatory submissions. Our services also include grant proposal writing for agencies like NIH, NSF, DoD, BARDA, DARPA, and NASA, as well as human factors and usability evaluations for medical devices, diagnostics, and software.
We provide team development, project management, and resource acquisition, along with financing and fundraising support for startups and established firms. Our services include strategic partnerships, global supply chain support, U.S. agency coordination for international life science and med-tech firms, and soft landing services for innovators in multiple regions.