The National Agency for Medicines and Medical Devices of Romania (NAMMDR) is established by reorganization of the former National Agency for Medicines and Medical Devices (NAMMD).
By strengthening the status of national competent authority in the field of human medicine and medical devices, while operating with an ethical and civic sense to ensure that all Romanian patients have access to innovative treatments, the new direction of the Agency will focus on the following aspects:
NewsPromising development for clinical studies in Romania
SCOPE International AG announces that The US Food and Drug Administration (FDA) has approved the new drug application (NDA) of an oral contraceptive for pregnancy prevention that was developed by one of our clients. SCOPE played a major role throughout the developmental process. The entirety of this endeavor involved 10 years of collaboration with the sponsor over 8 projects using 250 clinical sites where 5000 subjects were enrolled. SCOPE conducted dose finding studies, multiple phase II trials, and the phase III program in both Europe and the US.
NewsFDA Approval for oral contraceptive – teamwork to success
Scope International AG is proud to announce that its subsidiary in the United States, Scope International USA, Inc., was successfully inspected by the US Food and Drug Administration in June 2019.
The outcome of this FDA inspection is the most recent example of the high-quality results produced by the SCOPE team. Our clients can focus on the science of product development, while trusting SCOPE to follow the regulations and remain inspection ready at all times. Since the foundation of SCOPE in the year 2000, the company has successfully completed multiple FDA, EMA, and BfArM company inspections, along with countless inspections of sites that were a part of SCOPE clinical trials.
NewsScope International announces successful FDA inspection
We are excited to announce that SCOPE will be participating in the 9th annual Outsourcing in Clinical Trials Europe 2019 in Milan, Italy. Our Head of Biostatistics will give a talk titled „Efficiency through Quality by Design – How QbD will help in defining your outsourcing strategy”.
Scope International AG is pleased to announce the appointment of Björn Boße as new head of biostatistics. Together with Dr. Klaus Junge as Senior Biostatisticial Advisor Scope International offers an exceptional expertise in biostatistics. Björn and Klaus have both more than 20 years of experience in the pharmaceutical industry as e.g. Director Biostatistics and Executive Director European Biostatistics, respectively. Due to their outstanding expert knowledge in many indications, they will contribute to expanding several business areas of SCOPE.
NewsSpotlight on our Biostatistic experts and strategic consulting team
Scope International AG is pleased to announce the appointment of Adam Braithwaite as the key contact for Business Development in the U.S. Adam will join the SCOPE BD team as part of its North American subsidiary, Scope International USA, based in Pittsburgh, PA. In his new position, he will support our clients for their ongoing needs and will support the development of future products together with our customers.
NewsAdam Braithwaite appointed to the Business Development Team for the U.S.