Quality Control, Analytical Development & Quality Assurance

Quality Control, Analytical Development & Quality Assurance

In pharmaceuticals, quality is everything. With expertise in chemistry, assay development, stability, quality control and quality assurance, DDR is a leader in ensuring that your processes meet the strictest of quality standards and that your human resources are utilized to their fullest.

Past projects have included:

Case Study:  Stability Data

Initial Client Contact: Loss of stability program manager, no clear business process for obtaining, viewing, processing and disposition of data from contract labs;

  • Reviewed both vendor data on stability testing and production of observation memos
  • Performed trending analysis on stability data
  • Discovered significant issues—majority of stability data being used without complete review
  • Assisted in design of stability data review business processes
  • Designed training slides for CQC SOPs
  • Trained stability staff on data review
  • Wrote regulatory filings based on stability data
  • Trained staff on methods

Quantitative Impacts: 100% of stability data now reviewed. DDR able to run program for client more accurately and less expensively than hiring internal staff.