Our Analytical lab is your gateway to regulatory success
Analytical Services – Reliability at every step
- Analytical and bio-analytical method development, validation and life-cycle management (AQbD)
- TGA accredited laboratory
- Optimisation and validation of client’s existing analytical methods
- Testing drug products for API, preservative and antioxidant assays, impurities, degradation products and associated reporting
- API characterisation services for DMF requirements
- Forced degradation & stress studies to understand degradation pathways of drug substances and products; API-excipient compatibility studies
- Specialisation in UPLC, HPLC, GC, ELSD & other analytical laboratory services
- Facilitate technology transfer of client’s methods to 3rd party laboratories / CMOs
- Particle size distribution testing, method development and validation
- Methods and specifications developed to required regulatory requirements
- Studies to support your regulatory requirements e.g. ICH, USP, Ph.Eur, JP
- Speak to us about your reverse engineering needs
Applications include:
- Pharmaceuticals, Biotech
- Academia, Universities, Institutes
- Veterinary products
- Cosmeceuticals, Dermaceuticals
- Complimentary medicines
- Industrial
With specialised services and scientists for every application
- HPLC, UHPLC and UPLC
- FTIR
- Gas Chromatography (FID)
- ELSD, RI, UV and PDA detection
- UV Spectrophotometry
- Water content analysis – KF
- Laser diffraction particle analyser
- Photostability chamber
- Stability chambers
- Turbiscan
- Freezers and fridges
- Texture analyser
- IVRT diffusion apparatus
- Light microscopy
- Rheometer
- Viscometer
- Densiometer
- Autoclave
- QDa Mass Detector
- Surface tension
- Osmometer
- pH
- Specific gravity
- Ovens
- TLC
- Type I Water / RO Water systems