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Tagged: FDA

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

November 30th, 2022 | FDA

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  

BBCR can help medical device companies with clinical data strategy from conception to market, from preparing due-diligence ready datasets for funders to post-marketing safety surveillance for regulatory authorities.

July 6th, 2022 | FDA

Medical devices have their own special complications as it relates to clinical trials. We work closely with each client to bring device innovation to market faster and more affordably. Working with the BBCR team will help that streamlines clinical trials and help you get through the process faster and more efficiently. BBCR consulting offers the […]

BBCR has developed an approach to meet the challenges of researchers and innovators seeking a clearer path to market. Learn more about the advantages of our Strategic Clinical Innovation Organization (SCIO) concept.

December 15th, 2021 | FDA

We aim to transform the transition stage between pre-clinical and clinical endpoints with smart strategy that, at a minimum, redirects the costs to benefit patients. The FDA has been calling for a smarter, more innovative approach, and we believe SCIO is the integrative, multidisciplinary approach to deliver it. Why SCIO? Investing in Strategy Accelerate Patient […]

Drug Repurposing can lower the need for early stage clinical trials. BBCR’s team of industry experts can help match treatments to rare genetic conditions and unsolved diseases.

December 9th, 2021 | FDA

According to recently released data, 12 out of the 28 drugs approved in the first quarter of 2020 by the FDA were repurposed drugs. The drug repurposing approval process is an effective tool that accelerates the development of drugs for new indications or drug reformulation. In addition, the development of drug repurposing compared to a […]

Medical device companies need to think about clinical data strategy from conception to market, from preparing due-diligence ready datasets for funders to post-marketing safety surveillance for regulatory authorities. BBCR can help.

November 22nd, 2021 | FDA

Medical devices have their own special complications as it relates to clinical trials. We work closely with each client to bring device innovation to market faster and more affordably. Working with the BBCR team will help that streamlines clinical trials and help you get through the process faster and more efficiently. March 2021, the FDA […]

IND submission’s main objective is to obtain approval from FDA to perform clinical trials of an investigational medicinal product (IMP) in humans in the US.

August 18th, 2020 | FDA

The IND requires very detailed product and development data such as information related to manufacturing, data from nonclinical studies, and previous clinical studies related to the IMP. IND also requires a comprehensive source of documentation including study reports. It follows the CTD structure developed by ICH and is mandatory to be submitted in the eCTD […]

FDA approved mesenchymal stem cell (MSC) treatments as compassionate use in the very sickest COVID-19 patients.

April 22nd, 2020 | FDA

A pilot study in China in which seven COVID-19 patients received intravenous infusions of donor mesenchymal stem cells (MSC) indicates that the intervention was safe, and that the approach may improve infection outcomes was reported in Aging and Disease last month. We understand that it is only a small number of cases, and studies in […]

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