Service

Quality

 

Our Quality services include, preparation of a validation master plan (VMP) , traceability matrices (TM), qualification and validation of facilities, equipment and systems, quality system documentation, deviation management, corrective and preventative action (CAPA), sampling, recall systems and quality audits.

APC can develop a Quality Management System (QMS) tailored for your business.  Our consultants can carry out a gap analysis on your QMS and provide remediation advice or prepare/revise QMS documentation.

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All services

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GMP, Quality and Quality Systems

All aspects of facility, site and equipment planning from concept to audit.

GMP Engineering and Consulting

GMP facility design and review, for a green field site, site expansion, or laboratories.

Validation/Qualification

Within international regulatory standards for pharmaceutical and medical devices.

Project Management

Project planning, all documentation and construction support.

Quality Auditing

Auditing to standards required by Regulatory bodies in most countries.

Training

On site or virtual sessions tailored your needs.

Regulatory Affairs

After thorough research we guide our clients through product specifications and dossiers for submission

Contracting Staff

Qualified staff ready to assist you with all aspects of quality and regulatory matters.