Advanced Drug Product Analytical Services
Our analytical laboratory specialises in delivering comprehensive analytical services that are critical for successful drug development, testing and release. From complex product to method development and troubleshooting, we offer the insight you need at every stage.
When ready, we handle the analytical method transfer into GMP, supporting seamless integration into final quality testing.
Our Capabilities at a Glance
- Method development and qualification for drug product
- Method validation
- Drug product assay and purity (HPLC/GC)
- Particle size distribution (laser diffraction, sieve analysis)
- Size exclusion chromatography
- Excipient compatibility testing
- Stability testing
- Solubility studies
- Reverse engineering of existing drug products, both quantitative and qualitative
- Dissolution testing and method development (USP I, II, III and IV)
- Excipient analysis (MW, monomer ratio, reactivity, deg. of substitution, impurities, reducing power, end group quantity)
- Excipient nitrate and nitrite analysis
- Leachables and extractables studies
- Compatibility testing and in-use studies
Our Latest News and Insights
09 Jul 25
Pharmaceutical Dissolution Testing Theory
28 Nov 24
Accelerating drug development using 505(b)(2) regulatory pathways
12 Mar 24
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Work shoulder-to-shoulder with a family-owned CDMO and pharmaceutical supplier that answers quickly, solves early, and keeps your progress steady. Decisions feel clearer with us beside you.