A successful drug development strategy is a well-designed and dynamic process. Making sure regulatory requirements are embedded from the start, is key. From pre-clinical all the way to registration, a well-organized set of action plans needs to be in place that guides and accelerates the client’s vision on how to support their targeted therapeutic area.
CR2O (www.cr2o.nl) and 3D-PharmXchange (3d-pxc.com) are celebrating 2 years of successful ongoing collaboration on a number of pre- and clinical development programs for Biotech/Pharma SMEs. Together we designed, planned, oversaw and optimized multiple clinical-stage development programs. Amongst others our partnership has led to a well-defined CMC, regulatory and clinical development strategy for a new drug treating Female Sexual Disfunction including obtaining scientific and technical advice at EMA and FDA paving the way for the start of confirmatory trials in Europe and US.
Both companies also joined forces in delivering CMC, clinical development and clinical operational expertise allowing a vaccine produced on a new innovative yeast based production platform to be tested in a First-in-Human study. The use of this novel platform will lead to affordable, scalable, protective and safe vaccines.
Our highly qualified and experienced Life Sciences professionals are supported by CR2O’s rigorous clinical quality management system and continuous training programs, enabling delivery of top-quality clinical services. Senior experts were selected based on their ability to answer to the client’s development program’s specific requirements. The combined teams of Non-Clinical, Clinical, CMC and Regulatory experts all had hands-on experience from leading Big Pharma company teams.
Going from bench to the patient’s bedside is the dream of any scientist. Working smarter can make this goal a reality. Having a clear plan and guidance from the first tests all the way to the final drug product is crucial. Being able to combine CR2O’s operational clinical expertise with Clinical Science, CMC, Regulatory Affairs and Non-Clinical expertise was shown to be vital in those projects.
CR2O and 3D-PharmXchange remain committed with enthusiasm to the responsibilities that we assumed together towards customers and partners. We have successfully inspired difficult projects with novel ideas and insights, thereby significantly increasing the chance of success. We are constantly developing and stimulating ourselves to be able to take on the challenges of our complex field with pride.