By Dr. Scott E. Boley and Greg Ruppert
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. Read more.
The Benefits Of Contract Manufacturing
By Oliver Mueller and Clifford Mintz, PhD, Suzhou Pharma Services
Contract manufacturing organizations (CMOs) offer a wide array of manufacturing services to the pharmaceutical and biotechnology industries. These services can range from production of small quantities of materials for R&D purposes, larger amounts for clinical study usage, and ultimately, full-scale production for commercial purposes. The global contract manufacturing market primarily includes solid and liquid dosage forms and injectables. Read more.
The Global PV Landscape-Considerations Beyond The U.S. And EU
By Norwich Pharmaceuticals
The World Health Organization describes pharmacovigilance as the process of detecting, assessing, understanding, and preventing adverse events associated with medicinal products, with the aim of enhancing patient care and safety. While the goal of pharmacovigilance remains constant, the methods, resources, and regulations that are designed to reach this goal are continuously being updated and optimized. Read more.
Expedite Development While Ensuring Successful Commercial Outcomes
As regulatory expectations continue to evolve in the area of pharmaceutical development, working with contract research and manufacturing organizations (CRMOs) that couple execution experience with high-end technical capabilities and contemporary quality systems will ensure the most value from strategic partnerships and enhance a project’s progress on its path toward commercialization. Read more.