HeliPharm Consulting LLC

HeliPharm Consulting LLC is a woman-owned business providing the following consulting services to pharmaceutical and biotechnology companies: * CMC Technical Excellence – we have extensive hands-on experience in all stages of small-molecule drug product development * CDMO Management - we have a deep understanding and broad connection to the global CDMO network for solid oral therapeutics which allows us to help you identify and engage the best partner for your project * Regulatory Technical Writing Support – we have a solid knowledge of authoring CMC Module 3 and we have contributed to several NDAs and numerous INDs including several breakthrough therapy designations received from the FDA Our goal is to be a true partner to pharmaceutical and biotechnology companies and to exceed expectations by driving the best project results for your drug development needs, ensuring alignment with your business goals.