Dark Horse Consulting
Dark Horse Consulting (DHC) is the only practice in the world exclusively focused on Chemistry, Manufacturing & Controls (CMC) for cell & gene therapy products. Within CMC we have multiple specialists, ranging from process, analytical and manufacturing sciences, to tech transfer, in-house and CMO manufacturing support, quality and deep international regulatory expertise. Over the last five years DHC has provided invaluable service to over 60 clients worldwide, ranging from Israel, through Europe and North America to the Pacific Rim. The phase of development of such products has spanned academic pre-clinical, through IND/CTA, Phase I, II & III clinical trials and commercial operations. DHC has also successfully represented clients to the regulatory authorities in the above regions, such as the FDA, EMA, Health Canada and the KFDA. DHC has liaised between many clients and their Contract Manufacturing Organizations (CMOs), and has worked constructively with every cell & gene therapy-focused CMO in Western Europe and North America. Its founder, Anthony Davies, is a highly sought-after keynote speaker at national and international meetings.