FDA Oversight An Investigational New Drug (IND) application is required before your product can be studied in a clinical trial for a medical outcome. The IND application presents a case to the FDA arguing that your … Read More
Getting Started The first step is to contact us to set up a conference call. This complimentary 60-90 minute call enables our team to learn more about your project and your team’s end goals. We recommend … Read More
FDA Drug Approval. Start to Finish. Step 1: Preparation The first step is to plan your strategy. Do you want to make a structure and function claim or a drug claim? Structure & Function Claims: If … Read More
How do you develop an FDA-approved drug? Discovery & Development: This is typically the longest phase of the process. During this time, you are identifying active ingredients and developing your formulation. Pre-Clinical Drug Development: For most … Read More
Clinical Trials in 3 Steps Step 1: The Start Up Period Immediately after coming to an agreement on a clinical research partnership, the FSIHS Research team begins the Start-Up Period, which is the most labor-intensive step … Read More
See how our expertise makes clinical research budget-friendly Clinical trials in the integrative health world are typically seen as luxury expenditures, far exceeding the budgets of most companies in the field. After all, a research team … Read More
The FSIHS Research Center investigates botanical products, dietary ingredients, nutraceuticals, and dietary supplements for safety and efficacy. Our team conducts a wide range of human research studies, including clinical trials.