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  Consulting Services 

  • 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
  • Providing third-party audit to Stability Program
  • Serving as Trial Expert Witness


  CRO Management 


Pharmalytik provides project management oversight for activities at CROs around the globe. Projects include Stability Testing, Method Transfer, Method Validation, CMC documentation.

  1. Stability Testing: Develop Stability Protocols, Coordinate Sample Shipping and Study Set-Up, Review Data and Report
  2. Method Transfer: Develop Transfer Strategies, Coordinate activities among sites, Develop Transfer Protocols, Assemble Reports, Troubleshoot Transfer failures
  3. Method Validation: Work with CROs to develop and validate Analytical Method, Develop Validation Protocols, Review Validation Reports
  4. CMC Documentation: Review Analytical Development, Assemble and/or Review Stability Section.
  5. 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

Highlights

  • Coming soon.

"Introduction of Pharmaceutical Analysis"

Expected in September 2016,
John Wiley & Sons Publisher.

by K. Huynh-Ba (ed.)



Pharmaceutical Stability Testing to Support Global Markets

February 2010,
Springer Publisher & AAPS.

by K. Huynh-Ba (ed.)



"Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices"

November 2008,
Springer Publisher.

by K. Huynh-Ba (ed.)


Contact Info



Pharmalytik

Newark, DE USA


info@pharmalytik.com


(302) 731-9959