• Need a US Registered Agent

• Submit a 510(k)

• Improve Quality System (Policies, Procedures, Work Instructions, Forms, Validations)

• Corrective Action and Preventive Action (CAPA)

• On Site Audits - Internal (QIST) Audits, Supplier Audits

• Sterilization Process Consulting

Our  compliance specialists 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)

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FDA Compliance Help Desk™

1289 N. Fordham Blvd. Suite A-128

Chapel Hill, NC 27517 USA

Phone 919.942.1634

info@FDAcomplianceHelp.com

Copyright © 2004 - 2008 FDA Compliance Help Desk, Inc.
Last modified: 11/18/2008

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.