Bernd Renger Consulting

Bernd Renger Consulting is providing Consultancy Services for Pharmaceutical and related Industries including API, excipient and packaging material production and pharmaceutical testing laboratories; also serving Medical Device Manufacturers.

• GMP and GDP compliance checks including remediation plans
• Design and Implementation of Quality Systems, including Deviation Management, CAPA, Complaint Management, Change Control, Batch Record Review, Document Management, and Risk Management
• Preparation for FDA and National authority inspections – gap and risk assessment, mock inspections, audit preparation projects
• Inspection Finding Remediation Services (including FDA Warning Letter and 483s)
• Review and optimization of manufacturing and quality operations with emphasize on sterile and aseptic processes
• Contract Auditing Services – All types of pharmaceutical or medical device operations; manufacturing including aseptic manufacturing; Quality Systems, API manufacturing, excipient manufacturing, packaging components including glass tube manufacturing
• In-house training: National and international regulations, basic GMPs, relevant cGMP Guidance
• QP Services

BioLAGO industry

Competencies