BBCR’s experienced team in Regulatory Affairs FDA and EMA assists clients in simplifying complex and evolving regulatory processes.

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– Boston Biotech Clinical Research (BBCR). Strategic Clinical Innovation Experts. Rare Disease, Clinical Trials, Clinical Research, & Biologics. We work with biotech, pharmaceutical, and device companies to develop clinical/regulatory road-maps consisting with simplified clinical programs, streamlined protocols, and cost-effective clinical trials. Our experienced team provides innovative strategies that meet your goals.

by | Nov 30, 2022 | Medical Affairs and Clinical Research, Real World Evidence, Strategy and TPP

BBCR’s experienced team in Regulatory Affairs FDA and EMA assists clients in simplifying complex and evolving regulatory processes.

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.

Our expertise spans:

  • Regulatory Strategy
  • FDA Meeting & Submission
  • Pre-IND Integrated Development Plan
  • Regulatory Submissions

Contact BBCR 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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