REGULATORY CONSULTATION
The team offers a harmonized Israel Minister of Health and US FDA regulatory plan to minimize product development time and accelerate US FDA approval. A customized solution will help you navigate the complex and evolving US FDA regulatory environment to facilitate successful and timely Agency interactions, for small and large molecules, and from Class 1 to Class 3 medical devices.
ON-DEMAND EXPERTS
The on-demand team of seasoned experts employ a consultative, problem-solving approach, based on first understanding your unique goals, and then crafting a milestone based and flexible plan to achieve your goals.
Services include:
- Regulatory and clinical consulting and project management
- US FDA meeting representation
- Submission dossier services for drugs and medical devices
- Supplier sourcing and management for GLP testing and GMP manufacture
- US FDA Registered Agent services
The FDA Help Desk is a single point of contact to quickly answer questions relating to how your company would comply with FDA requirements or interact with the agency. We support both the Hebrew and English languages.
Learn moreCLINICAL SITE NETWORK
We have assembled a network of over 700 leading academic centers of excellence and phase 1 clinical study sites with world class investigators to support your clinical study requirements. This network allows you to reduce the risk and guess work associated with clinical site and investigator recruitment, and it will give you the support you need to meet your enrollment goals on time and within budget.
CAPITAL & COMMERCIAL SUPPORT
Business development is a required competency in an early stage company, especially in a resource-constrained environment. The ability to identify potential investors early and align your development plan to meet the expectations of the investors are critical to optimize value and the return on investment. CSSi LifeSciences has helped clients raise over $700M USD of capital over the past three years and can support client companies in their effort to raise capital and create go-to-market strategies that win. The Innosphere actively manages the Israel-Colorado Innovation Fund and the Innosphere Fund. The team’s industry experience and knowledge to connect companies to strategic investors and resources can rapidly accelerate a research discovery to commercialization.
A PLACE TO CALL HOME
State-of-the-art laboratories, manufacturing and office facilities are available through ongoing strategic partnerships with three Colorado research universities and over 12 leading US based accelerators. Educational programming is also routinely offered on the latest developments with the US FDA to help assess the impact on your technology and US commercial readiness.