Document preparation and submissions is critical to the success of bringing your product to market. Rely on the BBCR team to know what to submit and when for the most efficient process.

Documentation of clinical processes and preparing the essential paperwork for timely submission can open doors to expediting the approval process.

Boston Biotech Clinical Research can provide:

• Strategy and guidance for FDA meeting requests, briefing packages, preparation and attendance
• Author, review and publish original applications, amendments and supplements
• Prepare or assist in the preparation of regulatory submissions including medical devices, 510(k)s, PMAs, IDEs, de novos and Pre-Submissions

Contact BBCR today to learn more

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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