Yaohai Bio-Pharma provides Regulatory Affairs Services for biologics.
Our team can help devise tailored strategies and provide phase-appropriate regulatory support in all stages of development, including regulatory strategy consulting, Investigational New Drug Application (IND), Biologics License Application (BLA), and post-market.
We are experienced in Regulatory Affairs associated with recombinant biologics expressed in microbial systems (e.g., Escherichia coli, Yeast). We have been involved in the Regulatory Strategy Support and IND Submission Support for various modalities, including virus-vector vaccine, virus-like particle (VLP) vaccine, VLP carrier protein, cytokine (interleukin), fibroblast growth factor (FGF), transcription factors, IgG protease and Cas 9 nuclease for cell and gene therapy. Besides, our global partners can help you with global regulatory affairs, like IND/CTA, and BLA/MAA.
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