Regulatory Affairs FDA and EMA
Experience in simplifying complex and evolving regulatory processes
BBCR specializes in taking the complexity inherent to the regulatory affairs phase of the approvals and simplifying it by strategically supporting each client based on product-specific regulatory requirements and functional needs.
Regulatory Strategy
Thinking ahead during the regulatory affairs phase, 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 market is document preparation and submissions. You can rely on our team to know what to submit, and when for the most efficient process.
Pre-IND Integrated Development Plan
Hiring an expert consultant involved throughout the pre-IND preparation can pay great dividends.