Dr. Minghua Liu is an accomplished CMC consultant at ELIQUENT Life Sciences, with expertise in regulatory affairs and extensive experience supporting drug development from pre-IND to BLA submissions. She has successfully overseen over twenty IND CMC dossiers, ensuring FDA approval or supporting clinical hold-release. Dr. Liu has also represented ELIQUENT Life Sciences at the Bioprocessing Summit and multiple online conferences, delivering presentations on CMC regulatory strategies for mRNA-LNP products. In addition, she has authored several white papers across different platforms on various topics in both English and Chinese, sharing insights into CMC regulatory considerations. Her work aims to help sponsors better understand the latest trends in regulatory submission requirements. Dr. Liu’s broad knowledge spans mAb, ADC, mRNA-LNP, and CGTs, and she excels in facilitating regulatory communications and bridging language gaps for international clients.

Dr. Minghua Liu, as a seasoned CMC consultant at ELIQUENT Life Sciences, with extensive experience in regulatory affairs and product lifecycle management. Specializing in CMC biologics consulting, Dr. Liu has been instrumental in supporting both domestic and international companies throughout various phases of drug development, ensuring successful regulatory submissions and approvals.

During her tenure at ELIQUENT Life Sciences, Dr. Liu has successfully completed and reviewed over twenty IND CMC Module 3 dossiers, ensuring FDA approval or resolving clinical-hold issues. Her extensive expertise covers a broad spectrum of product types, consistently delivering high-quality results in complex regulatory environments.

Dr. Liu is highly skilled in regulatory submissions and has provided comprehensive support in critical communications with regulatory agencies, ensuring timely and effective responses throughout the review process. Her bilingual proficiency has been instrumental in bridging communication gaps with clients from China, helping them better understand and comply with FDA requirements.

In addition to her technical expertise, Dr. Liu has actively contributed to business development efforts, resulting in successful client engagements and new collaboration agreements. She is also recognized for her ability to enhance team efficiency through the development of databases and taking on additional workloads to ensure timely project completion.