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Welcome to APC
AP Consulting is a regulatory consulting firm
that specializes in FDA issues pertaining to medical devices and
dietary supplements. As a former Investigator’s Performance
Auditor
for FDA, I can help you to prepare for an FDA inspection. Hire
someone who used to do it as a professional career. We are
available to travel to most countries around the globe.
Contact AP
Consulting Today »
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Dietary Supplements
AP Consulting can help you market/import dietary
supplements in the U.S. We can help you with voluntary
dietary supplement adverse event reporting, and product
information such as labeling, claims, package inserts,
review Internet website, and accompanying literatures.
The Federal Trade Commission (FTC) regulates dietary
supplement advertising. Contact AP Consulting before you
market/import into the U.S.
We offer the following assistance to medical device
manufacturers:
- Dietary Supplement Health and Education Act of 1994
(DSHEA).
- Review labels and Supplement Facts panel.
- Structure and Function Claims.
- Adverse Event reporting.
- Registration and submissions.
- cGMP Inspection.
- The Bioterrorism Act of 2002.
- Assist with import issues.
AP Consulting can act as the U.S. Agent for any
non-U.S. dietary supplement manufacturer. The
responsibilities of the United States agent are:
- Assisting FDA in communications with the foreign
establishment,
- Responding to questions concerning the foreign
establishment’s products
that are imported or offered for import into the United
States, and
- Assisting FDA in scheduling inspections of the foreign
establishment.
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