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Drug Product
Balancing Speed with Depth in Formulation Development
We specialize in early-phase drug product formulation development. Our philosophy is to develop “fit-for-purpose” formulations in early phases to minimize complexity and accelerate timelines.
- Design formulations, e.g., API-in-bottle, API-in-capsule, capsule, tablet, solution, semisolid,
Process R&D/Drug Substance
Essential Groundwork for any Compound
Client medicinal chemistry processes commonly face multiple risks and challenges, including:
- Lengthy syntheses
- Multiple column chromatography steps
- Low-yielding reactions
- Scaling issues when moving from milligrams to hundreds of grams
- Hazardous reagents
- Non-environmentally friendly chemistries
- Reaction
Analytical R&D and Quality Control
Analytical Capabilities
Phase-Appropriate Approach to Develop User-Friendly Methods
Our analytical capabilities include services supporting process development, cGMP/AP| manufacturing and stability studies, and other stand-alone analytical projects.
Process Development
- Analytical Impurity Elucidation
- Analytical Method Development
- Reference Standard & Stability Studies
cGMP/API
Crystallization R&D
Crystallization R&D
Headed by science-centric subject matter experts, the Crystallization R&D is recognized as an industry preferred partner in solid form screening and selection, crystallization process development, pre-formulation, particle engineering and Drug Substance (DS) Drug Product (DP) co-processing. Applying over