We serve the highest quality for regulatory compliance. Many types of services are provided with our specialists to support both pre- and post-marketing phase in accordance with customer's requirement.
Raw materials : active ingredients and other excipients
Finished products : solid, liquid and semi-solid
In-process products : bulk mixtures of solid, liquid and semi-solid
Carefully develop and validate analytical methods which are performed according to many qualified tests complied with international standards and regulatory requirements. Parameters are considered including Linearity, Range, Precision, Accuracy, Selectivity, LOD, LOQ, Ruggedness and Robustness.
Stability is seriously monitored according to guideline which samples are stored at controlled well-defined specific or customised conditions. The stability studies are monitored in accelerated, long-term and stressed (forced degradation) conditions.