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We provide customized product development transfer and manufacturing services. We guarantee the supply of drugs throughout the product lifecycle from multiple scales. We make contract drug manufacturing easy. In our extensive contract development and manufacturing services portfolio we use advanced technologies to quickly and conveniently deliver products.
The Regulatory Affairs team has accumulated extensive experience in regulatory submissions to both China and overseas regulatory agencies including multiple NDA/BLA applications and over 30 IND applications. We can provide both regulatory and technical services throughout product lifecycle, from pre-IND to post-approval change.
Gap & risk assessment of research content, strategic and regulatory advice, CMC project planning, etc.
Preparation of CMC dossiers, including CN-IND/US-IND/IMPD/DSUR/IND amendment/NDA/BLA/PAC submissions, and review of regulatory documents to improve application success rate.
Meeting package preparation, meeting support with regulatory authorities.
Registration and inspection support: provide regulatory and technical support for information requests from Health Authorities, and support on-site facility inspections and other regulatory compliance activities.
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