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.

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