Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
SCIENTIFIC AND COMPLIANCE REVIEW
OF DATA AND REPORTS
SERVICE DESCRIPTION
In the modern work place there are often more tasks and too little time to be accomplished by the permanent staff. Moreover, work loads may have peaks and valleys, thus setting up the need for outside support. In addition sometimes it often valuable to have someone who is not intimately familiar with a project review the data and reports to make sure it makes sense and is in compliance with CGMPs. Some of the more time consuming tasks which lend them selves to outside support include:
• Methods validation data and report review
• Notebook and raw data review
• Batch record review
• Annual report review and updates
• Technology transfer report review
• Process validation data and report review
• Review of DQ/IQ/OQ/PQ documentation
• Assistance with LIMS and software validation
Delphi Analytical’s consulting staff’s skill sets spans every aspect of the pharmaceutical industry and can assist in lending this type of support.
WHO WILL VALUE FROM THE SERVICE
The following organizations will benefit from these services:
• Any company looking for an objective, outside third party review of data and reports.
• Any company who is experiencing peak work loads without the need or
resources to hire additional permanent staff.
PAST EXAMPLES
Some of Delphi’s past work has involved assisting companies in managing their outsourced contract work. Thishas included acting as reviewers of data and reports generated by numerous contract research organizations.
ADMINISTRATION
All consulting service contracts are individually negotiated. Please contact us directly for more details or to request a proposal or site visit.
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Consulting Services
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