Method Transfer and Validation

Whether your quality control strategy utilizes in-house resources, your contract manufacturer, a third party analytical testing laboratory, or all of the above, the effort to transfer and validate methods suitable for a commercial product is time consuming and management intensive. We can help! A partial list of related analytical projects we have undertaken includes:

Development of strategy and approaches to streamline method transfer or validation efforts
Validation of methods for product release, in-process controls, bioanalytical or biomarker methods, cleaning, and raw materials testing
Development, oversight, and review of documents related to method validation efforts, including:
- Validation Master Plans
- Development Lab characterization protocols and reports
- SOPs, batch records, stability reports and related GMP documents
Specification Development
Risk assessments and gap analysis
Coordination of method transfer and related technology transfer activities
Technical investigation of deviations, method failures, and out-of-specification results
Writing and review of related CMC sections for global regulatory submissions
Validation of related equipment, computer systems and other automated systems
Planning and performing equipment calibrations