Our Capabilities
Laboratory
Pharmaceutical Laboratory Capabilities
Quality CDMO provides in-house R&D, Quality Control, Microbiology, and Stability testing capabilities as part of our full turnkey manufacturing services. Our laboratories support product development, analytical testing, commercial manufacturing, product release and ongoing stability programs.
Advanced Laboratory & Quality Capabilities
- Analytical Testing & Method Development: Comprehensive method development, validation, cleaning validation, and process validation.
- Material & Product Testing: API, raw material, bulk, in-process, and finished product testing.
- Microbiological & Stability Services: Microbiological testing, stability studies, and summary reporting.
- Technical Support: Analytical troubleshooting and scale-up assistance
Analytical Capabilities & Instrumentation
- HPLC / UPLC: Multiple systems with a variety of detector configurations
- Gas Chromatography (GC) – Flame Ionization Detection (FID)
- Fourier Transform Infrared (FTIR) Spectroscopy
- Ultraviolet-Visible (UV-Vis) Spectroscopy
- Dissolution Testing – Automated sampling capability
- Water content determination
- Brookfield Viscometer
- Total Organic Carbon (TOC) Analysis – Automated Testing
- Analytical & Precision Balances
- pH & Conductivity Testing
- Density / Specific Gravity Measurement
- Controlled-Temperature Water Baths
- Stability Chambers
Microbiology Laboratory
- Microbiological Testing in accordance with applicable USP methods
- BOD Incubators
- Microscope
- Applicable Water and Product Microbiology
- Microbiological Support for R&D, Manufacturing and Quality
Programs
Stability Programs
- Quality CDMO supports stability programs throughout the product lifecycle, including:
- Shelf-Life Studies
- Stability Sample Testing, data review & stability summary reports
- Controlled stability conditions
- 25°C / 60% RH — Long-term stability
- 40°C / 75% RH — Accelerated stability
- Additional conditions may be supported as applicable to the approved study protocol and product requirements.
- Supporting the product lifecycle
R&D & Formulation → Analytical Method Development → Method Validation → In-Process & Bulk Testing → Finished Product Testing → Stability Studies → Data Review & Reporting
