We provide comprehensive services related to implementation of GMP system to pharmaceutical companies to obtain manufacturing/importation authorisation and GMP certificate. Based on mutual cooperation, we discuss, analyse and propose custom-tailored solutions, develop policies and procedures, conduct trainings  and internal audits.

When preparing and implementing the GMP system, we pay special attention to such an aspects as:

• personnel: trainings, experience,
• premises and equipment and its’ validation,
• supportive systems: HVAC, water and other installations,
• starting and packaging materials,
• compliance of conducted processes with medicinal product dossier and other law regulations,
• quality control laboratories,
• outsourced activities, including suppliers qualification, subcontractors audits, API audits
• complaints and recalls management,
• internal audits performance,
• system documentation and changes, deviations, OOS results management.

We ensure efficient and fast implementation of the company-specific GMP system.