- Overseeing cross-functional activities of the technical method transfer
- Overseeing outsourcing activities of analytical method development and validation
- Designing and writing level I, II and III conformance standards
- Strategic advisory of regulatory submission, stability program
- Writing or reviewing complete (or part of) the analytical development submission package
- Designing, writing or monitoring stability program for regulatory submission
- Designing and writing Standard Operating Procedures for Analytical Development
- Serving as Subject-Matter-Expert for laboratory investigation or stability investigation
- NEW! Providing third-party audit to Stability Program
Pharmalytik provides project management oversight for activities at CROs around the globe. Projects include Stability Testing, Method Transfer, Method Validation, CMC documentation.
- Stability Testing: Develop Stability Protocols, Coordinate Sample Shipping and Study Set-Up, Review Data and Report
- Method Transfer: Develop Transfer Strategies, Coordinate activities among sites, Develop Transfer Protocols, Assemble Reports, Troubleshoot Transfer failures
- Method Validation: Work with CROs to develop and validate Analytical Method, Develop Validation Protocols, Review Validation Reports
- CMC Documentation: Review Analytical Development, Assemble and/or Review Stability Section.
- Our services will be based on client request. Activities may be include, but not limit to, the followings:
- Develop timelines to manage projects
- Coordinate all defined activities
- Manage program within its budget
- Provide technical directions to CROs
