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 due-diligence, gap analysis, investigational new drug application (IND), biologics license application (BLA), and post-market.
With an experienced registration affair team familiar with Chinese regulations and policies, we are offering the most worthwhile registration solutions. We accurately grasp the biological registration trend through communication with medicine agencies. Besides, our global partners can help you with global regulatory affairs, like IND/clinical trial application (CTA), and BLA/ marketing authorisation application (MAA).
Regulatory Affairs Solutions by Yaohai Bio-Pharma
Regulatory Strategy Consulting
- Regulatory strategy
- Gap assessment
- Due-diligence
- Scientific advice
- Agency meeting support
IND/CTA and BLA/MAA
- Draft, review and submit CMC sections in the common technical document (CTD) format (Module 3, Module 2.3 and relevant Module 1 documentation)
- Agency meeting support
- IND/CTA and BLA/MAA submission
- Variation filings
Our Experience
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, as follows,
- Virus-like particle (VLP) vaccine
- VLP carrier protein and VLP conjugate vaccine
- Cytokine (interleukin)
- Fibroblast growth factor
- Transcription factors
- CRISPR-associated protein 9 (Cas9) protein for cell and gene therapy (CGT)
- Immunoglobulin G (IgG) protease
- Virus-vector vaccine
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