WuXi AppTec, Laboratory Testing Division published a blog post covering 5 things developers need to get right to navigate the EU regulatory strategy process, including Scientific Advice.

WuXi AppTec is a trusted partner and contributor to the pharmaceutical and life sciences industries, providing R&D and manufacturing services that help advance healthcare innovation. With operations across Asia, Europe, and North America, we offer integrated, end-to-end services through our unique CRDMO (Contract Research, Development, and Manufacturing Organization) platform. We are privileged to work alongside partners across 30+ countries, supporting their efforts to bring breakthrough treatments to patients. Guided by our vision that every drug can be made and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Our state-of-the-art Laboratory Testing Division provides leading bioanalytical & drug metabolism contract research services to a global customer base of pharmaceutical, biotech & agrochemical firms. Our bioanalytical services support a wide range of compounds-small & large molecules, new modalities including oligonucleotides, ADC, bispecific antibodies & more-from discovery to preclinical IND-enabling & regulated clinical studies. Capabilities include LC-MS/MS & immunochemistry platforms for GLP & non-GLP & customized Central Laboratory services to facilitate global clinical studies. Our comprehensive drug metabolism services are tailored to support the entire drug development cycle, from early discovery through IND-enabling to late-stage clinical development. Capabilities include in vivo pharmacokinetics, in vitro ADME, in vitro & in vivo biotransformation, & non-clinical radiolabel ADME (mass balance & QWBA).

Founded 1987