Global New Drug Development Services
Global Registration Applications
The "Three-in-One" registration service system covering full-range, global and full-process dimensions provides efficient, compliant and professional solutions for global drug registration applications.
Global Registration Applications
INTRODUCTION
INTRODUCTION
Bo Ji Pharmaceutical | Global Registration Strength — "Three-in-One" System, Professional Teams & US Subsidiary, Empowering Clients with Compliant & Efficient Global Drug Registration.
OUR SCALE
-
60+Communication Projects
-
70+Domestic IND Application Projects
-
40+Marketing Authorization Application (MAA) Projects (including ANDA, NDA and BLA)
-
100+FDA Investigational New Drug (IND) Application Projects
OUR ADVANTAGES
Service Scope Covers Major Global Markets
We are proficient in the pharmaceutical registration regulations and processes of multiple countries and regions, including China (NMPA), the United States (FDA), the European Union (EMA), and Canada (Health Canada), helping clients achieve the rapid global market launch of their products.
Senior and Professional Team
Nearly 60 registration experts, with practical experience in clinical research, preclinical research, CMC and project management, are well-versed in domestic and international regulations and equipped with extensive hands-on experience.
Project Management Mechanism
RA and PM collaborate to ensure the efficient progress of projects and seamless information alignment.
Global Network & Local Support
As Boji Pharmaceutical’s North American Registration Center, Humphries Pharmaceutical Services maintains offices in three locations—Mainland China, Hong Kong, and Maryland, USA—providing 24/7 uninterrupted cross-border communication and registration support. It has successfully served clients from the United States, China, Japan, Italy, and other countries. As of December 2024, Humphries has completed 15 FDA applications (including IND, Orphan Drug Designation/ODD, and Regenerative Medicine Advanced Therapy/RMAT) for cell therapy products on behalf of global clients, making it the registration consulting firm that has assisted the most domestic clients in completing such projects with the highest success rate.
SERVICE CONTENT
Chemical Drug Registration Services
- NMPA：New/Generic Drugs Clinical Application (IND), New Drug Application (NDA) & Generic Drug Application (ANDA), Filing of APIs, Excipients and Packaging Materials, Bioequivalence (BE) Filing, etc.
- FDA：505 (b)(1) & 505 (b)(2) Pathway Filings, Abbreviated New Drug Application (ANDA), Orphan Drug Designation (ODD), DMF Registration for APIs, Excipients and Packaging Materials, etc.
- EMA：Scientific Advice, Clinical Trial Application (CTA), Generic Drug Marketing Authorization Application (MAA), CEP/ASMF Applications for APIs, Excipients and Packaging Materials, etc.
Biological Products Registration Services
- NMPA：IND and NDA/BLA for Therapeutic and Preventive Biological Products (including antibodies, fusion proteins, Cell and Gene Therapy (CGT) products, etc.)
- FDA：Biologics IND, Orphan Drug Designation (ODD), Fast Track Designation (FTD) – formerly referenced as RPDD, and other strategic filings
Traditional Chinese Medicine
- China：Innovative Traditional Chinese Medicine (TCM) Drugs, TCM Drugs with the Same Name and Same Formula, Classical TCM Formulas, TCM Institutional Preparations, Protected TCM Varieties, Over-the-Counter (OTC) Conversion;
- International：TCM Registration in Hong Kong/Macao Special Administrative Region (SAR), US FDA Botanical Drug Investigational New Drug (IND) Application