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Consulting Services
QRC consulting services assist our clients in preparing
for FDA inspections (e.g. mock
inspections), Pre-Approval, BLA,
510 (K), and PMA inspections.
Additional consulting services
include providing problem
solving and resolution of
compliance and enforcement
issues, as well as providing
assistance to our
clients in directing, managing,
and responding to FDA
correspondence and FDA
inspectional observations (FDA
483 cites), and other enforcement
actions.
Some consulting services
include, but are not limited to
the following:
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FDA
Inspectional Observations (FDA
483), Review, Evaluation and
Response Preparation
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Problem solving
and resolution of FDA
compliance and enforcement
issue.
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Training in cGMPs (drugs,
devices, foods, biologic), DEA
and Q7A.
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Vendor/Supplier
Qualification
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Process and
Facility Validation
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CAPA
Review, Evaluation, and
Development
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Quality Manual
Review, Evaluation, and
Development
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Review,
Evaluation, and Development of
Standard Operating Procedures
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Bio-Research
Program, Review and Evaluation
e.g. IND,
NDA/ANDA, 510(k), and PMA
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Change Control
Program Review, Evaluation and
Development
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