ElixinPharma is dedicated to assisting new and emerging pharmaceutical companies with their Chemistry, Manufacturing and Controls (CMC) needs. Over the past twenty years, we have built a reputation for providing high quality, highly strategic management of the complex CMC issues surrounding novel technologies.
Our client base ranges from small venture-backed start-up companies to large multi-national pharmaceutical companies. We are intimately familiar with the challenges faced by start-up companies with respect to meeting development milestones, partnering issues, regulatory interactions and cash flow management. We work with these companies on topics beyond the science, helping to manage the development programs in a phase appropriate manner to better utilize limited resources while minimizing overall risk to the program.
As larger pharma companies have entered this field through maturation of their internal programs or through licensing agreements with smaller companies, new challenges have emerged; CMC and regulatory teams must adapt their internal systems, usually geared towards small molecule or protein therapeutics, to the unique requirements of oligonucleotides. We work with these teams to leverage their strengths while implementing innovative approaches to effectively manage the new programs.