Compliance Insight, Inc Successfully Assists Clients in Inspections and Applications

Compliance Insight Inc., a regulatory and quality assurance consulting firm, profiles a proven track record in successfully helping clients who are faced with challenging regulatory and quality assurance situations.
By: Compliance Insight, Inc.
 
April 20, 2013 - PRLog -- (Fairfield, Ohio) – Compliance Insight Inc., a regulatory and quality assurance consulting firm, profiles a proven track record in successfully helping clients who are faced with challenging regulatory and quality assurance situations.

Warning Letter Resolution
Compliance Insight was contacted by a medical device manufacturing company to help with a warning letter for a number of significant GMP inspectional observations. The follow-up inspection by the FDA was a complete success.

The organization took the following steps to help the client establish regulatory compliance:
1. Prepared warning letter response with a time line to complete each observation.
2. Provided periodic status updates to the FDA for the issues stated in the warning letter and notified them of the remedial action taken in each case.
3. Trained all the employees on Quality System Regulations and Good Manufacturing Practices.
4. Established Quality system at all levels of the organization.
5. Prepared and implemented procedures as per Quality System Regulations.
6. Communicated with the FDA on a continual basis to ensure that all pending issues were addressed satisfactorily.

Medical Device 510k & Canadian License Applications
A foreign manufacturer of Class II in-vitro diagnostic devices, seeking to market their products in the US and Canada, turned to Compliance Insight for assistance.  Working closely with the client’s US agent, Compliance Insight prepared and submitted a number of 510k applications to the FDA as well as license applications to Health Canada.  

The organization took the following approach to enable this manufacturer to legally market their products in the US and Canada:

1. Identified appropriate predicate devices for FDA 510k applications.
2. Obtained and reviewed necessary documentation from the client.
3. Developed protocols for clinical studies needed to demonstrate substantial equivalence to predicate devices per FDA requirements.
4. Helped coordinate, manage and review data from additional clinical studies required by FDA.
5. Prepared and filed submissions to FDA and Health Canada.
6. Provided FDA interface during their review and clearance process.
7. Assisted with device listing requirements.

The client now legally markets a number of in vitro diagnostic devices in the US and Canada. Compliance Insight provides continuing support to the client as new devices are developed.

Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and training for pharmaceutical, nutraceutical, medical device, chemical, and bio-technology companies in North America, Europe and Asia.

For more information visit http://compliance-insight1.com/
End
Source:Compliance Insight, Inc.
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Tags:Nutraceuticals, Compliance, Healthcare, Pharmaceutical, Manufacturing
Industry:Health, Medical
Location:United States
Subject:Reports
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