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.

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 market is document preparation and submissions. You can rely on our team to know what to submit, and when for the most efficient process.

Preparing for Pre-IND Meeting

Hiring an expert consultant involved throughout the pre-IND preparation can pay great dividends.

Visit BBCR Consulting

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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