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FDA QSR compliance (21 CFR 820: Quality System
Regulation/ Good Manufacturing Practices), ISO, Canada
CMDR, Japan PAL and other country requirements
Quality System Implementation
ASC’s consultants can successfully refine a current system
or implement a new System after performing an initial gap
analysis based on the current regulatory requirements for an
Organization. We also can verify that the change to the
current system or the deployment of a new system has been
executed to satisfaction.
Compliance
Regulation/ Good Manufacturing Practices), ISO, Canada
CMDR, Japan PAL and other country requirements
Quality System Implementation
ASC’s consultants can successfully refine a current system
or implement a new System after performing an initial gap
analysis based on the current regulatory requirements for an
Organization. We also can verify that the change to the
current system or the deployment of a new system has been
executed to satisfaction.
Compliance
- Preparation and corrective action plans for FDA 483
citations and warning letter responses - Import/export issues
- Promotional labeling and advertising issues
- FDA dispute resolution processes
- Product recall strategies
- Assist with FDA/ ISO/ Canada CMDR, Japan PAL
and Other country audits and system gaps.
Our Mission
© Advanced Solutions Consultants (ASC, LLC). All rights reserved.
| SERVICES: QUALITY COMPLIANCE |
To provide complete solutions to Quality, Regulatory, New Product Development and Compliance challenges. We are dedicated in supporting our clients in the Device, Diagnostics, Pharmaceutical, Biologics and Combination Product industries in maintaining high standards of Quality in their practices and in their products. We encourage you to contact us for more information. |
| Contact us: Admin@ASC-FL.com 954-344-8284 |
