HJB - Your Trusted Biologics CDMO Partner
HJB, CDMO, biologics, HJB Bio, hjbbio, China CDMO, 杭州奕安济世, Just Bio, Just biotherapeutics, HJB bio, HJB China, Hangzhou HJB
With extensive experience in successful IND filings across the U.S. and China, our team provides expert guidance in CMC strategy, interpretation, and submission in accordance with ICH, FDA, EMA, and NMPA regulations. We offer a full range of professional regulatory support services, including:
• Pre-IND meeting packages
• Preparation of IND filing documents
• Regulatory consultations
• Assistance throughout the IND filing process
Our goal is to help clients navigate regulatory complexities to achieve efficient and successful drug development.
We specialize in the preparation, writing, and review of CMC documents in CTD format. Our services include:
• Preparing CMC-related meeting materials
• Formulating comprehensive responses to health authority inquiries
• Submitting application documents in eCTD format to ensure regulatory compliance
By facilitating a seamless CMC submission process, we support our clients’ global regulatory success.
Our expert team provides strategic guidance on global regulatory frameworks, aligning with ICH guidelines and regulations from the FDA, EMA, NMPA, and other authorities. Our services include:
• Preparing comprehensive pre-IND packages and meeting materials
• Facilitating interactions with health authorities, including crafting responses to information requests (IRs)
• Defining phase-appropriate testing acceptance criteria to ensure compliance and reliability
• Conducting analytical comparability exercises throughout the IND phase and post-BLA to ensure method consistency
Performing thorough risk assessments on raw materials, manufacturing process, formulations, container closures, and product format changes.
Our mission is to develop clear, effective CMC strategies that enhances compliance, mitigate risks, and streamline the development and regulatory pathways for our clients’ products.
CDMO@hjbbio.com
