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
Tagged: EMA
BBCR’s experienced team in Regulatory Affairs FDA and EMA assists clients in simplifying complex and evolving regulatory processes.
November 30th, 2022 | EMADrug 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 | EMAAccording 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 […]