Industries and applications we support
Formulation manufacturers
Finished dosage forms — tablets, capsules, liquids and semi-solids — from pilot batches through commercial release.
- Batch release testing against specification
- Dissolution profiles and disintegration
- Assay and related substances by HPLC
- Ongoing and accelerated stability
API manufacturers
Active pharmaceutical ingredients and intermediates, where impurity profile and solvent residue decide acceptance.
- Assay and related substances
- Residual solvents by GC headspace
- Water content, LOD, sulphated ash
- Pharmacopeial monograph verification
R&D and development teams
Products still being defined, where the method has to be built and proven before any release data means anything.
- Method development and validation
- Forced degradation studies
- Dissolution method development
- Protocol and report writing
Contract manufacturers
Multiple products and multiple clients, each with its own specification and reporting expectation.
- Batch analysis across product lines
- COA issue per client specification
- Method transfer and verification
- Stability programmes per product
Where our work usually fits in your programme
Before the dossier
Method development, forced degradation and validation, so the analytical section of your filing stands up to review.
Between lab and plant
Exhibit and pilot batch analysis, dissolution comparison, and method transfer into your own QC laboratory.
Every batch after that
Routine release testing, COA issue, and the ongoing stability programme the product carries through its shelf life.