We operate a Medsafe-certified laboratory, which is approved to Good Manufacturing Practice (GMP – New Zealand) and Therapeutic Goods Administration (TGA – Australia) standards for raw material testing, stability trials, and finished product testing of natural products and dietary supplements. See our accreditations.
Testing services include:
- a fully Medsafe GMP/TGA certified and audited laboratory
- analysis of raw materials, intermediates and finished products
- full pharmacopoeia monograph testing
- development and validation of analytical methods
- performance of client-specific methodology
- development of monographs
- a complete microbiological testing service
- stability storage under ICH conditions
- product efficacy and preservative efficacy testing.
We are committed to working in collaboration with industry, and offer advice and customised analytical solutions for the natural products industry – as many natural products contain ingredients that do not have a monograph in a relevant pharmacopoeia.
We can help you with advice on:
- relevant tests
- the amount of validation required
- the most suitable method of analysis.
Using our experience and expertise, we develop robust analytical methods based on good analytical science, and offer full method development and validation capabilities.
We also validate testing methods to meet ICH guidelines.
Please contact us to discuss any of your method development or validation requirements.