Where ALKU Can Help

From remediation projects to new facilities or quality system improvements, ALKU can assume complete responsibility or simply act in an advisory capacity.

Quality

• Manufacturing
• Risk Management
• Process
• SOP Creation/Revision
• Design
• CAPA
• Supplier
• SCAR
• Investigators
• Complaints

Validation

• Process
• Utilities
• Cleaning
• Sterilization
• Software
• Method
• Computer Systems
• Equipment
• Facilities
• Instrumentation

Project Management

• Program Managers
• Technology Transfer PM
• Remediation PM
• UDI PM

Regulatory Affairs

• Submissions
• Supplements
• Strategy
• International Submissions
• Labeling
• International Strategy

ALKU in the press