Quality assurance

Have Any Questions?

Development, implementation and ongoing maintenance of quality assurance systems

We provide solutions to specific licensing problems and answers to questions on quality assurance.

Our quality assurance staff of 20 has the knowledge and experience needed to comply with European Union regulations.

How can we help?

Quality assurance support for pharmaceutical commercial activities
we have the answers to all your quality assurance questions related to wholesale, whether it's general pharmaceutical wholesale, off- premises pharmaceutical wholesale or wholesale of other categories of products
Quality assurance of plasma centres
complete design and operation of systems
Location service
provide the personnel and facilities for wholesale (GDP) or manufacturing (GMP) quality systems
Physical imports
we provide full process management for import procedures
Software
quality assurance for implementation and development
Building quality systems

Planning of licencing processes and preparation of full documentation:

We create and maintain all the documents you need to manage your pharmaceutical products, whether it’s SOPs, personnel and material conditions, quality assurance contracts or service provider and subcontractor agreements.

We help you make the critical decisions that determine whether your medicine will make it to market successfully.

Review and operation of quality assurance systems
Validation and certification
GMP/ GDP auditing
Inspection management, authority consultation
Performing quality assurance tasks of those entitled to marketing authorization
Authorised person, responsible person and deputy services
Quality assurance assistance service/background support
GMP advice, consultation
Provision of human, material and IT resources for the systems