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Not
sure if your company can pass a
GMP, GLP, GCP, Quality Systems, -
Part 11 & QSR Part 820 audit?
Standard 3 day on-site all
Inclusive Audit for $4,995.00 *details
(Good for 1 discipline audit
only)
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TAG
offers expertise in global GCP and GLP Quality Assurance and
Clinical Research. TAG principals, have over 25 years of
global experience in the drug and device industry working
for sponsor and CRO organizations in positions of QA,
Training and Development, Standard Operating Procedures, and
Clinical Research. TAG is also networked with other
consultants who assist with larger scale projects or niche
areas, such as Part 11 validation work or GMP process
validation. CV and references are available upon request.
* GCP Investigator site
audits in
preparation for regulatory submission
* CRO audits
to initially qualify
vendors and later verify ongoing performance
* GCP Training
of Clinical Monitors,
Medical Monitors and investigational site teams
* GLP audits
of studies for the QA
statement in the final report and of GLP vendors to qualify
and verify performance
* QC evaluations
of final study reports
prior to regulatory submission
*
For-cause (fraud and abuse) investigations
*
Standard Operating Procedure development
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