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Pre-Clinical Stage
Actual Development Timelines
One Stop Shop Services
Drug Discovery
Drug Design・Chemical Synthesis
Tailor-Made Amino Acids
Drug Discovery Program
Outsourced Supply
Pre-Clinical Study・Investigational New Drug
Scale Up・Process Development・Analysis Development
Development Timeline
Actual Development Timelines
High Potency Labs
Clinical Study
Process Optimization・GMP Production・Stability Test・Method Validation・Method Validation・Process Validation
Development Timeline
Actual Development Timelines
Outsourced Toll Manufacture
New Drug Application
Pre-Approval Inspection・Regulatory Filings
Reliable Quality Assurance
DMF and Regulatory Filings
Material Development
Plant Extraction Research
Plant Extraction Technology
Commercial Production
Actual Commercial Manufacture
DMF and Regulatory Filings
Outsourced Commercial Mfg
Actual Development Timeline Examples
We manage everything under GMP from receiving raw materials to packaging the finished substance
We have over 40 technical staff members and over 30 quality staff members who are eager to tackle any difficult situation
We have many reactors of different types and sizes to meet your quantity demands
We handle all validations!
With nearly 70 years’ experience, we perform scale up studies quickly and efficiently!
Actual Example of Active Pharmaceutical Ingredient Project
Total 5 Steps, GLP-API 2 Lots, GMP-API 1 Lot
Actual Example Advanced Intermediate Project
Total 7 Steps, GLP-ITM 2 Lots, GMP-ITM 3 Lots