AUK CONTRACTORS CO.,LTD.

AUK CONTRACTORS CO.,LTD.

Our Team of Former FDA Investigators and Staffers Ensure Compliance by Offering the Following Services:

FDA Compliance | Master Planning and Strategy | Preparation for Inspections | Pre-approval and Mock FDA Inspections | Vendor / Supplier Audits | Gap Analysis | Formal Risk Assessment | Support with 483′s / Warning Letters / Consent Decrees | Assistance and Review of Regulatory Filings (IND’s/PMA’s/NDA’s/ANDA’s/BLA’s/510(k)’s/etc.) | Quality Systems Guidance and Development | Corporate SOP Guidance and Development | Mock Product Recalls | Assistance with Product Recalls | Process and Utility Design Review and Assessment | Facility Layout Review and Assessment Dietary Supplements and Nutraceuticals and more…