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
We believe that understanding the perspective, challenges, and needs of our clients allows us to serve as a trusted adviser throughout the clinical development process. BBCR clients are domestic and international, small and medium sized drug and device biotechnology firms as well as venture capitalist. Clinical researchers and innovators come to us looking for the […]
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