The PDI offers an integrated approach to analytical method lifecycle to ensure newly developed methods are phase-appropriate and can perform all the way through the life of a commercial product.
We offer analytical method development/qualification laboratory services to enable phase-appropriate methodology in support of our client’s drug development program. Our method development scientists have >10 years of experience working with both small molecules and biologics in a variety of dosage forms including solids, patches, gels, ointments, liquids, and inhaled products. The PDI laboratories are equipped with sophisticated analytical instrumentation including chromatography, dissolution, mass spectrometry, and spectroscopy.
We provide:
- Specialists in the development of HPLC/UPLC stability-indicating methods, including forced degradation studies with key impurity identification.
- Support to ensure that your method will be ‘fit for purpose’ over the method lifecycle as it evolves from early-stage development through commercial use.
- Stability testing for API and drug products, including preliminary chemical stability tests (early stage), excipient compatibility, and informal stability studies under at least two different storage conditions – long-term ambient and accelerated conditions – to ensure a successful formal stability study.
- Routine batch release testing.
- Expert troubleshooting by analytical scientists who can assist with developing specifications for API/drug products.