Welcome to BioDuro-Sundia
Investigational New Drug (IND)
Our dedicated IND filing team is vital to your new drug research. Our one stop shop platform seamlessly integrates preclinical research services.
- IND Filing Solution
- Regulatory Consultation
- Research Service
- Project Management
- IND Application
Bioavailability Enhancement
Our company pioneered contract services to address poor solubility and bioavailability issues using amorphous solid dispersion (ASD) technologies. Our Solution Engine 2.0 currently allows screening ASD formulations with only 100 mg of API.
- ASD Screening Studies
- ASD Stability Studies (Spray Drying and Hot Melt Extrusion)
- ASD Process Scale Up and Clinical Trial Material (CTM) Manufacturing
- Preclinical formulations selection
- Compendial excipient screening
- API-sparing formulation screening
- Scale-up path from mg to metric tons
- Accelerated molecule to commercial product path
Category:
CMC: Biologics, Drug Substance CMC: Biologics, Drug Product CMC: Biologics, Analytical CMC: Biologics, Drug Delivery CMC: Small Molecules, Drug Substance CMC: Small Molecules, Drug Product CMC: Small Molecules, Analytical CMC: Small Molecules, Drug Delivery CMC: Small Molecules, Packaging Discovery: Discovery Chemistry Discovery: Discovery Biology Discovery: DMPK