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.
BBCR can assist clients in the following areas: Regulatory Strategy Thinking ahead during the regulatory process, we avoid unnecessary hurdles in the approvals process. We identify gaps, work through the right strategies for an effective product application, and prepare for label claims. FDA Meeting & Submission Critical to the success of bringing your product to […]