Jinjie Hu, PhD
Dr. Jinjie Hu is the founder of Axteria BioMed Consulting Inc.
Prior to Axteria, Dr. Hu was a senior consultant working at Biologics Consulting Group for more than 5 years. She has almost 12 years of experience with the Food and Drug Administration, Center for Biologic Research and Review. She was a senior expert regulatory/scientific reviewer with experience leading many review committees for 510 (k), IDE, PMA, IND and BLA. Dr. Hu also has extensive experience working with FDA in developing companion diagnostic products, combination products, and applications for Clinical Laboratory Improvement Amendments (CLIA) waivers. As a trained manufacturer facility reviewer and CGMP inspector, she performed many pre-approval inspections and helped company to resolve deficiency issues meeting QSR and cGMP. She has been serving as scientific advisor, dossier reviewer and manufacturer facility inspector for the In Vitro Diagnostic Pre-Qualification Program at WHO since 2009.
She provided leadership to collaborate with developing and emerging regulatory agencies for regulatory capacity building and training as the co- chair for the International Network Committee of the FDA Alumni Association.
Jinjie received her B.S. in Cell Biology from Beijing Normal University and her Ph.D. in Comparative Pathology from UC Davis.
Jinjie.hu@axteriabiomed.com
Rachael Chen
An expert in research, writing, and editing application, analytical, and clinical
study protocols and reports for FDA submissions, Rachel Chen provides Project
Management and submission support for original applications and lifecycle
management including EUA, 510(k), PMD, pre-submission, INDs, amendments,
and supplements. Ms. Chen serves as a U.S. Representative for foreign groups as
well as a primary regulatory contact for U.S.-based companies, managing
responses to information requests, coordinating and participating in FDA
meetings, associated rehearsals, and de-brieng activities.
Rachael graduated with a Bachelor of Science from University of Maryland College Park. Her work experience includes an internship at the National Cancer Institute Center for Cancer Research and a research laboratory assistant position at a biology laboratory at the University of Maryland College Park. She completed the first two year of medical school prior to joining Axteria BioMed Consulting. She currently serves as a project manager at Axteria BioMed Consulting and has been a part of the company since its inception.
rachael.lc@axteriabiomed.com
Dr. Guang Gao
Principal Consultant, RAC, CQA
Ph.D. Biochemistry, Nanjing University
With over three decades of experience in laboratory and clinical research, Dr. Gao
brings critical FDA regulatory experience (inspection, compliance, and
regulation) in GMP from a compliance/regulatory perspective. She has extensive
industry experience working on drug and device development and approval
strategies, and a substantive expertise in FDA requirements for these areas. Dr.
Gao’s skillset also includes preparation and response to Warning Letters and
Inspectional Observations, regulatory meeting preparation, and responses to
FDA review letters. She brings tremendous experience in the Chinese
pharmaceutical industry, and a full understanding of the Chinese regulatory
system for drugs, biologics, and medical devices, as well as working experience
in the WHO prequali cation program. At this time, Dr. Gao has served as the
primary or secondary author on 28 peer reviewed publications.
Yi Mei
Yi Mei is a regulatory affairs professional specializing in in vitro diagnostic devices. Prior to joining Axteria Biomed Consulting, Yi Mei contributed her expertise to WHO, where she provides specialized technical assistance to IVD manufacturers, advises on WHO Prequalification (PQ) and Expert Review Panel for Diagnostics (ERPD) pathways, and contributes to sustainable local production of quality-assured medical devices. Her role includes conducting document dossier review, providing recommendations on study protocols, designing training materials, and fostering partnerships to strengthen global health equity. She served as Regulatory Affairs Manager at several leading IVD companies, overseeing premarket authorizations, drafting FDA/EU submissions, and developing strategic compliance for multiple types of IVD devices. Yi Mei received her Master of Public Health from University of Sheffield and MSc in Bioinformatics in Fudan University. With deep regulatory acumen and passion for empowering IVD innovation, her career bridges industry expertise and global public health leadership, transforming regulatory challenges into solutions for underserved markets.
yi.mei@axteriabiomed.com
Christy Foreman
Ms. Foreman comes to AxteriaBioMed with over 28 years of federal service. She has
22 years of experience with the Food and Drug Administration (FDA), 18 of those years spent in the Center for Devices and Radiological Health. She has extensive experience with premarket regulatory programs (PMAs, 510(k)s, de novo applications, IDEs and pre-submissions) and well as good manufacturing practices including the Quality System Regulation and postmarket enforcement issues such as recalls, warning letters, seizures and injunctions for a wide variety of medical devices.
Christy began her career at the FDA in 1996 as a reviewer in the anesthesiology and defibrillator devices branch in the Office of Device Evaluation (ODE) where she also began serving as an FDA representative on several voluntary consensus standards for medical devices. She entered management as the Branch Chief for orthopedic, physical medicine and anesthesiology devices in the Office of Compliance. She went on to become the deputy division director in the Office of Compliance for the division responsible for orthopedic physical medicine, anesthesiology, cardiovascular, neurology and radiology devices. She then returned to ODE as the served as the deputy office director from 2008 – 2010 and the director of ODE from 2010-2014. She was instrumental in the development and implementation of the 510(k) plan of action, implementation of new legislation such as FDASIA and user fee negotiations with industry.
In 2014 Ms. Foreman joined the Center for Tobacco Products as the Associate Director for Regulatory Programs in the Office of Compliance and Enforcement where she developed new regulatory programs and regulations, including manufacturing regulations, in the newest Center in the FDA.
Christy received her BBE in Biomedical Engineering in 1993 and her MBE in Biomedical Engineering in 2000, both from The Catholic University of America.
Christy's background and wealth of knowledge makes her an ideal strategic partner to:
• Advise clients on short and long term regulatory strategies for medical devices and combination products
• Assist in the development of Quality Systems
• Prepare medical device regulatory submissions, including 510(k), PMA, HDE, RFD, 513(g), preSub, and IDE
• Represent clients in interactions with FDA; assists clients in the preparation for Advisory Panel meetings
• Provide in-house training on FDA Regulatory issues and new policy developments
christy.foreman@axteriabiomed.com
Calley Hardin
Calley has been a consultant in the medical device industry since 2007. She came to consulting with over 8 years of experience in various technical engineering roles, including 3 years of experience as a Biomedical reviewer at FDA in the Office of Device Evaluation, Division of General, Restorative and Neurological Devices, General Surgery Devices Branch. At FDA, Calley was involved in the review process for 510(k)s, IDEs and as lead reviewer for PMAs. Calley’s combination of industry and FDA experience positions her to provide clients with a specialized understanding of regulatory processes and the challenges they may encounter when interacting with the agency.
Calley holds a B.S. in Biomedical and Electrical Engineering from Vanderbilt University.
As a Principal Consultant at AxteriaBioMed Calley utilizes her technical and regulatory expertise to assist clients in the following areas:
• Review, prepare and submit all types of medical device regulatory submissions
• Technical support and review of bench testing, software documentation, risk analysis and device technical specifications for regulatory submissions
• Review and prepare quality system documentation
• Project management services for all types of regulatory projects