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A-pharmaconsult Quality Assurance for Drugs & Medical Devices
As a specialist in Quality and Regulatory Affairs, A-pharmaconsult can provide a full range of quality assurance (QA) support services to ensure consistency and full regulatory compliance for pharmaceutical drug products and medical devices.
These QA services draw on the accumulated knowledge and expertise of the A-pharmaconsult team that includes medical professionals and engineers who are highly versed in all relevant quality, clinical, medical and scientific regulatory affairs fields within depth experience in regulatory compliance consultancy.
Through tailored programmes, A-pharmaconsult can support clients in optimizing their manufacturing practices and general operations to meet the highest quality standards. It can also provide support in planning, documenting and preparing audits and inspections.
Quality Assurance for Drug Products
A-pharmaconsult has in-depth knowledge of every aspect of the Quality Assurance process in drug development, manufacturing and marketing. It can assist with compliance checks regarding the requirements of quality assurance, along with guidance in the complex range of tasks and documentation required by GxP guidelines, including Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP).
The QA team is also able to assist with documentation maintenance (proceedings), pharma industry-specific concepts such as deviations, change control, risk assessment, etc., and planning, documentation and preparation for audits and inspections within GDP, GMP and GCP.
Quality Assurance for Medical Devices
A-pharmaconsult offers a full range of consulting services for the design & development, writing of the Technical Documentation according to MDR 2017/745, and CE marking process of medical devices, providing support in such aspects as evaluation and updating of client’s current QA system to ISO13485, and expertise in development of the product.
The QA team is also able to assist with documentation maintenance, medical devices-specific concepts such as PMS/PMCF, usability, risk analysis, etc., and planning, documentation and preparation for audits and inspections within ISO 13485:2016 and MDR 2017/745.
The medical devices experts can also provide support for writing of technical documentation for Class I, II or III medical devices according to EU current regulations.
Other QA services
A-pharmaconsult can also offers a full range of consulting services for the development, writing of the Product Information File (PIF) and notification of Cosmetics in areas such as detailed classification and evaluation of products, writing of product labelling and regulatory dossier, evaluation of promotional materials, notification to Authorities and evaluation and update of current QA system.
Across the board, A-pharmaconsult can assist with QA advice plus development assistance to comply with quality requirements. Implementation/update of a Quality Management System to comply with GxP, ISO 13485, and ISO 22716 guidelines.
Click on A-pharmaconsult Quality Assurance Services for further information.