CuriRx scientists can create analytical methods to support your CMC. We develop methods for drug substances and products from scratch, improve and expand existing methods, and even troubleshoot existing problems. Our scientists therefore create methods that will generate information to eventually support the rapid testing of preclinical samples, formulation prototypes, and commercial samples. The resulting official test methods can be used by quality control laboratories to ensure the identity, purity, potency, and performance of said products.
These are the steps most common to analytical development projects:
Method development plans
Generation of test procedures
Methods validation/qualification protocols
Validation/qualification test method generation