BBCR specializes in taking the complexity inherent to the regulatory phase of the approvals and simplifying it by strategizing our support to each client based on product-specific regulatory requirements and functional needs. Our expertise spans: Regulatory Strategy FDA Meeting & Submission Pre-IND Integrated Development Plan Regulatory Submissions
Rare disease drug development requires knowledge and experience that is not always intuitive or deductible from large population drug development experience. Looking for a Rare Disease drug development expert, both in regulatory and medical affairs, is highly recommended. We’d love to hear from you.
A strategy that clearly marks the path to success creates opportunity to reduce risk. BBCR works with clients to achieve a successful pre-IND meeting by: Reviewing scientific data Setting regulatory strategy Setting integrated plan Creating messages and outlines Developing realistic Q&As Providing constructive critique
Did you know that about a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs? Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. We invite you to learn more about how BBCR can […]
According to recently released data, 12 out of the 28 drugs approved in the first quarter of 2020 by the FDA were repurposed drugs. The drug repurposing approval process is an effective tool that accelerates the development of drugs for new indications or drug reformulation. In addition, the development of drug repurposing compared to a […]