Sophia

Quality

Solutions

About Sophia Quality Solutions

Regulatory News

Services

Sophia Quality Solutions offers services and expertise in the following areas:

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Contract Qualified Person services can be provided to meet the clients specific needs.

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Release of Medicinal Products and Medical Device Products to the market place.
Preparation of Quality Documentation e.g. Product Quality Reviews, Quality Manuals, Quality Agreements.
Implementation of corrective action and remediation programs.

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A comprehensive audit of the clients Quality Management System can be undertaken to determine deficiencies.
Design and implementation of a Quality Management System to meet regulatory expectations.
Preparation of specific documentation required to support the Quality Management System.
Identifying continuous improvement opportunities within the Quality Management System.

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Auditing against EU GMPs, FDA GMPs, ISO 9001, ISO 13485, ISO 22716 and ISO 14644 standards.
Internal Auditing.
External Auditing of Finished Product Manufacturers, API plants, Warehouses, Suppliers, Service providers.
Preparation and inspection readiness for Regulatory Audits.

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Design and delivery of customised training programs and assessments covering GMP and Regulatory topics.
Design of workshops and presentation of industry case studies.
Development of company training plans.
Oversee and monitor deliverables of training plans.

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Management of quality improvement and document management projects.

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