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:
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Analytical Assay Development
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Method Transfer and Validation
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Testing Lab Selection and Management
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Development of Stability Protocols
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Management of Stability Programs
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GMP Facility and System Audits
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Development and Management of Document Systems
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Quality Investigations
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Quality Oversight of Operations
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.