About Cbr international corp.
CBR International Corp. is a leading global product development, clinical oversight, and regulatory operations group that offers comprehensive lab to launch program development services. The company has been providing its services for many years and has gained a reputation as one of the most reliable and efficient service providers in the industry.
The company's primary focus is on assisting companies with COVID-19 development programs and FDA's Coronavirus Treatment Acceleration Program (CTAP). CBR International Corp. has been at the forefront of developing innovative solutions to combat COVID-19 since the outbreak began. The company's team of experts works tirelessly to provide clients with cutting-edge solutions that meet their specific needs.
One of the key strengths of CBR International Corp. is its ability to provide end-to-end product development services, from concept design to commercialization. The company's team comprises highly skilled professionals who have extensive experience in various fields such as engineering, chemistry, biology, regulatory affairs, clinical research, project management, and quality assurance.
CBR International Corp.'s lab-to-launch program development services include product ideation & conceptualization; feasibility studies; prototyping & testing; design control & verification/validation; manufacturing process validation; quality system implementation & compliance support; regulatory strategy & submissions support (FDA/EMA); clinical trial planning & execution (Phase I-IV); post-market surveillance activities (PMS); medical writing support for technical documentation preparation (e.g., IND/IDE/NDA/BLA).
The company also provides comprehensive clinical oversight services that include site selection & qualification; investigator recruitment training & management; protocol design review/approval/supporting documents preparation (e.g., ICFs); monitoring activities including remote monitoring capabilities using advanced technologies like eSource/ePRO/eCOA/eConsent etc.; data management including EDC systems implementation/supporting documents preparation(e.g., DMPs) ; statistical analysis plan preparation/review/approval/reporting ; safety reporting including SAE reconciliation/reporting ; medical monitoring including AE/SAE review/approval.
In addition to these core offerings, CBR International Corp.'s regulatory operations group provides clients with expert guidance on navigating complex regulations governing drug/device/biologic products' approval processes worldwide. This includes assistance with FDA submissions such as IND/IDE/NDA/BLA applications or other international equivalents like MAA/CMA etc.; pre-submission meetings with regulators/filing strategies advice/guidance on responding to agency questions or deficiencies letters during review cycles until final approval/denial decisions are made by authorities.
CBR International Corp.'s commitment to excellence is evident in its track record of success stories across various therapeutic areas such as oncology/hematology/infectious diseases/neurology/cardiology/metabolic disorders/rare diseases etc.. The company has helped numerous clients achieve their goals by providing them with customized solutions tailored specifically for their unique needs.
In conclusion,CBR International Corp.is an industry leader in global product development,cinical oversight,and regulatory operations.Their expertise lies in providing end-to-end solutions from concept design through commercialization.They have a proven track record across various therapeutic areas,and they are currently assisting companies with COVID-19 developments programs.Clients can trust them for innovative solutions tailored specifically for their unique needs.CBR international corp.is your go-to partner if you want your products developed efficiently while meeting all necessary regulations globally!
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