Quality Assurance services

A-pharmaconsult offers you  a range of comprehensive QA services to help to ensure safety and consistency in medical products and devices. Through tailored programmes we support you as our client, to optimise your manufacturing practices, and general operations to meet the highest standards possible.

We can also help our clients in planning, documenting and preparing audits and inspections. Our team is able to help your staff to adapt to through changing conditions in all healthcare sectors.

Quality Assurance - Drugs

A-pharmaconsult has been a part of every aspect of the Quality Assurance tasks. We can provide:

• Compliance checks regarding the requirements of quality assurance 
• Guidance and tasks regarding Good Manufacturing Practice
• Guidance and tasks regarding Good Distribution Practice
• Guidance and tasks regarding Good Clinical Practice
• Assist with documentation maintenance (proceedings)
• Industry specific concepts such as deviations, change control, risk assessment and much more.
• Planning, documenting and preparing audits and inspections within GDP, GMP and GCP

Quality Assurance - Medical Devices

A-pharmaconsult offers a full range of consulting services for the development and registration of medical devices. We can provide:

• Evaluation and update of your current Quality Assurance system to ISO13485
• Expertise in classification and evaluation of your product
• Writing of technical dossier for Class I, II or III medical devices according to EU current regulations.

Quality Assurance - Food and Food supplements

A-pharmaconsult offers a full range of consulting services for the development and notification of Food and Food Supplements. We can provide:

• Expertise in the classification
• Evaluation of product
• Writing of product labelling
• Evaluation of promotional materials
• Notification to the Authorities
• Evaluation and update of your current Quality Assurance system

Quality Assurance - Cosmetics

A-pharmaconsult offers a full range of consulting services for the development and notification of Cosmetics. We can provide:

• Evaluation and update of your current Quality Assurance system to ISO22716
• Expertise in the evaluation of product
• Writing of product labelling
• Evaluation of promotional material
• Writing of dossiers for Cosmetics including Safety reports, according to EU current regulations
• Notification to the Authorities.