Technical excellence with a client-focused approach and Precised development
Our CMC R&D services include formulation development and analytical method development support for solid oral dosage forms including complex formulations. Formulation development activities include pre-formulation, material characterization, solubility enhancement and final formulation. Analytical method development activities focus on developing and validating drug substance and drug product testing methods for Quality Control (QC). One of our primary expertise is the development and validation of discriminatory dissolution method for various dosage forms.
We also provide release and stability testing services for drug substances and drug products to support investigational and commercial products.
Discriminatory dissolution method development
- Biorelevant dissolution (FaSSIF/FeSSIF conditions)
- IVIVC (in vitro–in vivo correlation) modeling
- Discriminatory dissolution method for complex dosage forms
- Supersaturation & precipitation studies (critical for ASD)
- GI simulation models (pH shift, gastric to intestinal transition)
Pre-formulation & Developability Studies
-
Solubility profiling (pH, solvents, surfactants)
-
pKa and partition coefficient
-
Solid-state characterization
-
Functional group analysis and identification
-
Excipient compatibility studies and Molecular mobility
-
Amorphous/crystalline distinction
Solubility Enhancement and Formulation
- Expertise in enhancing solubility on poorly soluble compounds
- Slow dissolution
- Variable absorption
- Low oral bioavailability
- Formulation development
Material Characterization Tests
- Particle size analysis
- Morphology
- Optical microscopy
- Molecular mobility
- Amorphous/crystalline distinction
Controlled & Modified Release for Complex Dosage Forms
- USP Apparatus III & IV methods
- Release kinetics modeling
- Polymer matrix evaluation
- Complex dosage forms release profile
Stability-Indicating Analytical Solutions
-
Forced degradation studies
-
Stability-indicating method development
-
Dissolution under stability conditions
Release testing for Drug Substance and Drug product
- Assay (potency testing)
- Impurity profiling / related substances
- Stability testing (ICH conditions)
- Method development & validation
- Dissolution sample analysis
- Cleaning validation samples