Services

GXP PharmAid helps pharmaceutical companies with:

• Achieving § 39 approvals
• Audits
     - Internal audits
     - External audits (contract makers & suppliers)
• Qualified Person (QP)
• Master Batch Record (MBR)
• Review of batch documentation
• Qualifications & Validations
• GMP quality system (build, optimize and maintain)
• Develop and revise SOP's
• Deviation Handling
• Change Control Management
• OOS handling
• CAPA Management
• Root Cause Analysis
• Handling of Complaints
• PQR (Product Quality Review) preparation
• Education and training of staff
• Consulting concerning premises and equipment
• General quality consultancy
• Preparation and review of contracts
• QA improvement projects (organization, processes, systems)
• Tech transfer
• Risk assessment
• Quality by Design Implementation
• Medical Device Quality Support
• ISO quality support

GXP PharmAid carries out reviews of the company quality assurance systems and monitors and implement upgrades, enabling them to meet both the company, the Danish authorities, the EU and the FDA GMP requirements.