FDA
Compliance Help Experienced • Effective •
Affordable
Clients get better results through outsourcing - FDA submissions,
documentation, procedure writing, validations, internal auditing,
employee training, complaint handling (MDR), and CAPA projects.
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 For
a free consultation call
Washington, DC 1-202-241-3407
Chapel
Hill, NC 1-919-942-1634
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Services:
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510(k)
Premarket Notification Submissions
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Quality
Systems (Policies, Procedures, Work Instructions, Forms,
Validations)
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Corrective Action and Preventive Action (CAPA)
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On Site
Audits - Internal (QIST) Audits, Supplier Audits
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EtO Sterilization Validation, Audits,
and Troubleshooting with reference to ISO 11135, TIR 14,15,
16
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Complaint Investigation, Record
Keeping in US, and Adverse Event Reporting Service
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US Registered
Agent Service
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Our associates have served leading life science firms including: |
American Hospital Supply
▪ Edward Weck
▪ Flow Laboratories
▪ Genesis Medical
▪ Johnson & Johnson
▪ Steris Corporation
▪ ICN Biomedical
▪ Teleflex Medical
▪ Meadox Medicals
▪ Synthes
▪ Riley Medical
▪ Pilling Surgical
▪ Surgicot
▪ Rx Textiles ▪
QCP (Drug Packager)
Request Availability and Price Quote
no risk or obligation
FDA Compliance Help Desk,
Inc. is a for profit NC corporation and is not affiliated with the U.S.
Department of Health and Human Services.
FDA Compliance Help Desk, Inc.
1289 N. Fordham Blvd.
Suite A-128
Chapel Hill, NC 27517 USA