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- FDA/ ISO "mock" inspections (GMP, GLP, cGMP,
GCP) - Due diligence audits and assessments
- Follow-up Compliance Audits
- Pre-Approval Inspection (PAI) readiness
- Supplier Audits
Audits:
- FDA Mock Audits: Expert auditing services for our
international and domestic clients can be provided by
our third party auditors to perform gap assessments
and identify risks and provide recommendations for
any corrective actions. - Our auditors can also prepare the staff at the client
site for managing an FDA/ ISO inspection. - General Audits: Conduct audits according to Good
Manufacturing Practices GMP’s/cGMP’s,Good
Clinical Practices/GCPs, Good Laboratory
Practices/GLPs, International Standards Organization
Series ISO 9000, ISO 13485, ISO 14000, Canada
CMDR, Japan PAL and Other Country requirements.
Inspections:
Facilities inspections
- Process
- Systems
- New Facility
Our Mission
© Advanced Solutions Consultants (ASC,LLC). All rights reserved.
| SERVICES: AUDITS/ INSPECTIONS |
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 |
