Audit & ConsultingWe support your business with the following services:
• Project monitoring
• Building up quality systems
• Developing documents
• Contacting medicines authorities
• Preparation of application for GMP certification
• Assistance in obtaining manufacturing authorization
• Consulting on applications for marketing authorization of medicinal products
GMP ConsultingConsultants team supports you on all GMP inspection preparation steps:
• Analysis of the current GMP status of a site
• Audit report and CAPA development
• CAPA support:
• GMP training
• SOP Writing and Review Services
• Audit of suppliers and contract manufacturers
• Qualification and validation
• CAPA implementation control
GDP AuditGood Distribution Practice Audits
All stakeholders in the supply chain of medicinal products need to comply with GDP requirements in accordance with the European Guideline since September 2013.
Manufacturers of medicinal products are in charge to check that the products will be distributed under controlled conditions, that`s why, wholesalers, transport companies, warehouses and other partners in the supply chain will have to be selected thoroughly.
Data integrityEnsuring data integrity at the pharmaceutical business is an important task. Data integrity is the sum total of arrangements which ensuring that data, irrespective of the process, format or technology in which it is generated, recorded, processed, retained, retrieved and used will ensure a complete, consistent and accurate record throughout the data lifecycle.