CMC testing services & facilites
QualityThroughput
Our proven track record takes new chemical entities (NCE) and repurposed active pharmaceutical ingredients (API) from the laboratory to market-ready MDI products. With expertise in pressurised formulation complexities and rigorous regulatory standards, we deliver stability and compliance.
High Speed Testing with Uncompromising Quality
We craft essential IP that enhances performance, extends patent life, and secures equity for your venture, clinical endeavours, and market strategies. Our focus on formulation and device IP is backed by a history of groundbreaking MDI patents spanning three decades.
Our Services
With over 75 years combined expertise in product formulation and characterisation, our management team can provide robust scientific solutions to enable your company to develop effective therapeutic products. We offer specialist services for aerosol-based products.
Our laboratories can provide pharmaceutical testing of orally inhaled MDI and liquid products with rapid turn-around following our MDISprint team methodology. We have facilities for the manufacture, characterisation and study of inhalation products. Testing protocols include:
Analytical method set up and validation
package robustness
orientation studies
content uniformity & dose reproducibility
Pharmacopeia aerosol analysis
API dissolution
stability & accelerated stability studies
particle size analysis
moisture interaction & content
foreign particle analysis
method development & validation
manufacture and scale up consultancy
Pharma storage facilities